Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

2023-504743-13-00 Protocol 78934804UCO2001 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 30 Nov 2022 · Status Ongoing, recruitment ended · 20 EU/EEA countries · 130 sites · Protocol 78934804UCO2001

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 752
Countries 20
Sites 130

Moderately to Severely Active Ulcerative Colitis

To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)

Key facts

Sponsor
Janssen - Cilag International
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20]
Trial duration
30 Nov 2022 → ongoing
Decision date (initial)
2024-05-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Janssen Research & Development, United States

External identifiers

EU CT number
2023-504743-13-00
EudraCT number
2021-005528-39

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Efficacy, Others, Pharmacodynamic, Safety, Dose response, Pharmacogenomic

To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)

Conditions and MedDRA coding

Moderately to Severely Active Ulcerative Colitis

VersionLevelCodeTermSystem organ class
20.1 LLT 10045365 Ulcerative colitis 10017947

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
  2. Moderately to severely active UC as assessed by the modified mayo score
  3. Demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effects
  4. If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion criteria 5

  1. Has severe extensive colitis as defined in the protocol
  2. Extent of inflammatory disease limited to the rectum
  3. Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
  4. Has a history of, or ongoing, chronic or recurrent infectious disease
  5. Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Clinical remission at Week 48 compared with each monotherapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

JNJ-78934804

PRD11001931 · Product

Active substance
Guselkumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
240 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Comparator 2

Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL

PRD2827309 · Product

Active substance
Guselkumab
Pharmaceutical form
INJECTION/INFUSION
Route of administration
SUBCUTANEOUS USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
240 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Golimumab

PRD11082758 · Product

Active substance
Golimumab
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
SUBCUTANEOUS USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
240 Week(s)
Authorisation status
Not Authorised
MA holder
JANSSEN-CILAG INTERNATIONAL N.V.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to Guselkumab and Golimumab and JNJ-78934804

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

109 Total trials 22 Recruiting 86 Ended
Commercial
Sponsor organisation
Janssen - Cilag International
Address
Turnhoutseweg 30
City
Beerse
Postcode
2340
Country
Belgium

Scientific contact point

Organisation
Janssen - Cilag International
Contact name
Clinical Registry Groupp

Public contact point

Organisation
Janssen - Cilag International
Contact name
Clinical Registry Group

Third parties 7

OrganisationCity, countryDuties
Bioclinica Inc.
ORG-100033079
 Philadelphia, United States Other, E-data capture
Yprime LLC
ORG-100042888
 Malvern, United States Other, E-data capture
Alimentiv Inc.
ORG-100006515
 London, Canada Other, E-data capture
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland On site monitoring, Code 12, Code 2, Data management, Code 9
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Excelya Greece CRO Single Member S.A.
ORG-100009224
 Nea Filadelfia, Greece On site monitoring, Other, Code 2
Almac Clinical Technologies LLC
ORG-100043036
 Souderton, United States Other

Locations

20 EU/EEA countries · 130 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 3 4
Belgium Ongoing, recruitment ended 8 1
Bulgaria Ongoing, recruitment ended 13 6
Croatia Ongoing, recruitment ended 3 1
Czechia Ongoing, recruitment ended 12 3
Denmark Ended 5 5
Estonia Ended 5 3
France Ongoing, recruitment ended 36 16
Germany Ongoing, recruitment ended 73 17
Greece Ongoing, recruitment ended 15 4
Hungary Ongoing, recruitment ended 18 6
Italy Ongoing, recruitment ended 25 12
Netherlands Ongoing, recruitment ended 9 3
Norway Ongoing, recruitment ended 9 3
Poland Ongoing, recruitment ended 95 25
Portugal Ongoing, recruitment ended 3 5
Slovakia Ongoing, recruitment ended 32 4
Slovenia Ongoing, recruitment ended 8 1
Spain Ongoing, recruitment ended 8 8
Sweden Ended 3 3
Rest of world
Japan, Chile, Australia, United States, Ukraine, India, Brazil, Argentina, Korea, Republic of, United Kingdom, Israel, Switzerland, Taiwan, Russian Federation, Canada, New Zealand, Jordan
 — 369 —

Investigational sites

Austria

4 sites · Ongoing, recruitment ended
Krankenhaus Der Barmherzigen Brueder Wien
Gastroenterologie und Nephrologie, Johannes-Von-Gott-Platz 1, Leopoldstadt, Vienna
Klinikum Wels-Grieskirchen GmbH
Abteilung für Innere Medizin I, Grieskirchner Strasse 42, 4600, Wels
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Innere Medizin I, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Gastroenterologie, Hepatologie, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

1 site · Ongoing, recruitment ended
Az Maria Middelares Gent
BE10003: Gastro-enterologie, Buitenring-Sint-Denijs 30, 9000, Gent

Bulgaria

6 sites · Ongoing, recruitment ended
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
BG10002: Gastroenterology, Oborishte Distr., Ul.Byalo More 8, Sofia
Diagnostic-Consultative Center Alexandrovska EOOD
BG10006, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
BG10007, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Medical Center Hipokrat 2000 OOD
BG10005: Gastroenterology, 12-14 Stefan Karadzha Str, 6300, Haskovo
First Private MHAT Vratsa
BG10003: Department of Internal Medicine, 95 General Leonov str., 3000, Vratsa
Medical Center Medica Plus Ltd.
BG10001, Ulitsa Sergey Rumyantsev 63, 5006, Veliko Tirnovo

Croatia

1 site · Ongoing, recruitment ended
KBC Split
HR10004: Gastroenterology, Spinciceva 1, 21000, Split

Czechia

3 sites · Ongoing, recruitment ended
Iscare a.s.
CZ10003:IBD a gastroenterologie, Ceskomoravska 2510/19, Liben, Prague
Fakultni Nemocnice Brno
CZ10002:lnterni gastroenterologicka klinika, Jihlavska 340/20, Bohunice, Brno
Vojenska Nemocnice Brno
CZ10005:Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice

Denmark

5 sites · Ended
Region Hovedstaden
DK10002:Unit: Mave, -Tarm og leversygdomme Klinik 3, Borgmester Ib Juuls Vej 31, 2730, Herlev
Aarhus Universitetshospital
DK10007:Clinical trial unit, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
DK10003:Gastroenterology, J B Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
DK10001:Department of Medical Gastroenterology, Moelleparkvej 4, 9000, Aalborg
Bispebjerg og Frederiksberg Hospital
DK10004:Gastroenterology, Ebba Lunds Vej 44, 2400, Kovenhavn

Estonia

3 sites · Ended
East Tallinn Central Hospital
EE10002: Cardiology, Ravi Tn 18, Kesklinna Linnaosa, Tallinn
Laane-Tallinna Keskhaigla AS
EE10003: Gastroenterology, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
Tartu University Hospital
EE10001: Gastroenterology, A006, L. Puusepa Tn 8, Tartu Linn

France

16 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire Grenoble Alpes
FR0007: Hepato-Gastroenterology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nice
FR10014: Gastro-Entérologie, Hépatologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Lille
FR10021: Gastroentérologie, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire Amiens Picardie
FR10004: Service Hepato-Gastroenterolog, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHRU De Nancy
FR10010: Service d'Hépato- Gastroentérologie, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Assistance Publique Hopitaux De Paris
FR10011: Hepato-Gastro-Enterologie, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Universitaire De Montpellier
FR10019: Service d’Hépato-Gastroentérologie et Transplantation, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Saint Etienne
FR10015: Hepatologie, Gastroentérologie (HGE) et d'oncologie digestive, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Nimes
FR10001: Gastroenterology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Departemental Vendee
FR10013: Département d’Hépato-Gastro-Entérologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Hospices Civils De Lyon
FR10018: Hépato-Gastroentérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
FR10009: Service d’Hépato-Gastro-Entérologie, 178 Rue Des Renouillers, 92701, Colombes Cedex
Centre Hospitalier Universitaire De Bordeaux
FR10020: Hépato-gastroentérologie et d', Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Toulouse
FR10006: Hépato-Gastroentérologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Medico Chirurgical Ambroise Pare Hartmann
FR10008: Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Regional De Marseille
FR10005: Hépato-Gastroentérologie, 265 Chemin Des Bourrely, 13015, Marseille

Germany

17 sites · Ongoing, recruitment ended
Eugastro GmbH
Gastroenterologie und Hepatologie am Johannisplatz, Johannisplatz 1, Zentrum Sudost, Leipzig
Goethe University Frankfurt
Medizinische Klinik I, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Technische Universitaet Dresden
Universitätsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 1, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin IV, Am Klinikum 1, Lobeda, Jena
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Hindenburgdamm 30, Lichterfelde, Berlin
MVZ Gastro Berlin
Gastro -Studien GbR, Gastroenterologie am Bayerischen Platz, Innsbrucker Straße 58, 10825, Berlin
Universitat Heidelberg
Med. Fak. Mannheim d. Univ. Heidelberg, UMM, II. Med. Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Krankenhaus Waldfriede e.V.
Gastroenterologie, Argentinische Allee 40, Zehlendorf, Berlin
Gastroenterologische Gemeinschaftspraxis Minden
Gastroenterologie, Uferstrasse 3, 32423, Minden
MVZ Portal 10
Gastroenterologie, Albersloher Weg 10B, 48155, Munster
Praxis fuer Gastroenterologie Prof. Dr. med. R. Ehehalt
Gastroenterologie, Bergheimerstr. 59-61, 69115, Heidelberg
Studiengesellschaft Jakobeit UG
Gastroenterologie, Hochstrasse 49, 51688, Wipperfuerth
Universitaetsklinikum Ulm AöR
Gastroenterologie, Endokrinolo, Albert-Einstein-Allee 23, Eselsberg, Ulm
Martin-Luther-Universitaet Halle-Wittenberg
Gastroenterologie, Pneumologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Dr. med. Thomas Brunk Gastroenterologie Berlin
Gastroenterologie, Ehrenfelsstrasse 47, 10318, Berlin-Karlshorst
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Unternehmergesellschaft (haftungsbeschränkt), Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)

Greece

4 sites · Ongoing, recruitment ended
Ippokratio General Hospital Of Thessaloniki
GR10001: B Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Alexandra Hospital
GR10006: Gastroenterology Clinic, Vassilissas Sofias Avenue 80, 115 28, Athens
Thoracic General Hospital Of Athens I Sotiria
GR10005: 3rd Internal Clinic, Messogion Avenue 152, 115 27, Athens
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I
GR10003: Gastroenterology Clinic, Dimitrios Mantouvalos Str. 3, 184 54, Νikaia

Hungary

6 sites · Ongoing, recruitment ended
Pannonia Maganorvosi Centrum Kft.
HU10003, Pannonia Utca 35-37, 1136, Budapest XIII
Central Hospital Of Northern Pest Military Hospital
HU10005: Gasztroenterológia Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Gyongyosi Bugat Pal Korhaz
HU10001: Gasztroenterológiai Egység, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
HU10007: Gasztroenterológiai és Belgyógyászati Osztály, Markusovszky Str. 5, 9700, Szombathely
University Of Szeged
HU10002: Gasztroenterológiai Osztály, Kalvaria Sugarut 57, 6725, Szeged
Semmelweis University
HU10006, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII

Italy

12 sites · Ongoing, recruitment ended
Azienda Ospedaliera Universitaria Gaetano Martino Messina
IT10005: UOC Gastroenterologia e Malattie Intestinali Croniche, Via Consolare Valeria N 1, 98124, Messina
Ospedale San Raffaele S.r.l.
IT10004: Gastroenterologia ed endoscopia digestiva, Via Olgettina 60, 20132, Milan
University Hospital Consorziale Policlinico
IT10009: Gastroenterologia Universitaria, Piazzale Giulio Cesare 11, 70124, Bari
Fondazione IRCCS San Gerardo Dei Tintori
IT10010: SC Gastroenterologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
IRCCS Ospedale Sacro Cuore Don Calabria
IT10013: Unità Operativa Complessa di Gastroenterologia ed Endoscopia digestiva - IBD Unit, Via Don Angelo Sempreboni 5, 37024, Negrar
Casa Sollievo Della Sofferenza
IT10002: Gastroenterologia e Endoscopia Digestiva, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Cagliari
IT10001: Gastroenterologia, Strada Statale 554 N. 1, 09042, Monserrato
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IT10006: UOC Medicina Interna e Gastroenterologia, Largo Agostino Gemelli 8, 00168, Rome
Humanitas Research Hospital
IT10014: IBD center, Malattie Infiammatorie Croniche Intestinali, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
IT10012: UOS Dipartimentale di Malattie Infiammatorie Croniche dell'Intestino (MICI), Via Trabucco 180, 90146, Palermo
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
IT10011: UOC di Gastroenterologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Per L'Emergenza Cannizzaro
IT10003: UOC chirurgia generale – IBD Unit, Via Messina 829, 95126, Catania

Netherlands

3 sites · Ongoing, recruitment ended
Amsterdam UMC Stichting
NL10002: Gastroenterology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
NL10006: Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
NL10003: Department of Gastroenterology and Hepatology, Heidelberglaan 100, 3584 CX, Utrecht

Norway

3 sites · Ongoing, recruitment ended
Akershus University Hospital
NO10003: Gastrolab B202, Sykehusveien 27, 1478, Lorenskog
Oslo University Hospital HF
NO10004: Gastroenterology, Taarnbygget, Kirkeveien 166, Oslo
Baerum Sykehus
NO10009: Gastroenterology, Sogneprest Munthe-Kaas Vei 100, 1346, Gjettum

Poland

25 sites · Ongoing, recruitment ended
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
PL10006: ETG Zamosc, Ul. Spadek 41, 22-400, Zamosc
Melita Medical Sp. z o.o.
PL10021: Centrum Medyczne Melita Medical, Ul. Gen. Romualda Traugutta 1-7, 50-449, Wroclaw
Klinika Reuma Park Sp. z o.o. S.K.
PL10026: Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Centrum Medyczne Medyk Sp. z o.o.
PL10016: Centrum Medyczne Medyk, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Medical Network Sp. z o.o.
PL10028: Medical Network Sp. z o. o. WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Amicare Sp. z o.o. sp.k.
PL10011: Gastroenterologia, Ul. Zgierska 249, 91-495, Lodz
Wojewodzki Szpital Specjalistyczny W Olsztynie
PL10010: Oddzial Gastroenterologiczny, Ul. Zolnierska 18, 10-561, Olsztyn
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
PL10032: Klinika Chorob Wewnetrznych i Gastroenterologii, Ul. Woloska 137, 02-507, Warsaw
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
PL10020: Poradnia Gastroenterologiczna, Ul. Barska 13, 87-800, Wloclawek
EMC Instytut Medyczny S.A.
PL10013: EuroMediCare Szpital Specjalistyczny z Przychodnia, Ul. Pilczycka 144/148, 54-144, Wroclaw
Reumed Sp. z o.o.
PL10015: Zespol Poradni Specjalistycznych REUMED ONYKSOWA Filia nr 2, Ul. Onyksowa 10, 20-582, Lublin
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
PL10023: Twoja Przychodnia - SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Sonomed Sp. z o.o.
PL10027: Gastroeneterologia, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Endoskopia Sp. z o.o.
PL10018: Poradnia Gastroenterologiczna, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Bodyclinic Sp. z o.o. sp.k.
PL10029: Gastroeneterologia, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Promed P.Lach R.Glowacki Sp. j.
PL10025: Centrum Medyczne PROMED, Ul. Olszanska 5g, 31-513, Cracow
NZOZ Vivamed Jadwiga Miecz
PL10033: Gastroenterologia, ul. Zamiejska 17, 03-580, Warszawa
Gastromed Sp. z o.o.
PL10024: Gastroeneterologia, Ul. Grudziadzka 11/13-14, 87-100, Torun
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
PL10009: ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Centrum Medyczne Oporow
PL10034: Gastroenterologia, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
PL10014: Centrum Medyczne Plejady, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
PL10017: Twoja Przychodnia PCM, Os. Lecha 15a, 61-293, Poznan
Rivermed Sp. z o.o.
PL10035: Gabinety Lekarskie RIVERMED, Ul. 28 Czerwca 1956 R. Nr 382/u4, 61-441, Poznan
Vistamed & Vertigo Sp. z o.o.
PL10022: Gastroenterologia, Ul Raclawicka 105 1b, 53-149, Wroclaw
Manermed Sp. z o.o.
PL10019: Centrum Medyczne "Medis", Ul. Garbary 5/l4, 85-229, Bydgoszcz

Portugal

5 sites · Ongoing, recruitment ended
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
PT10004: Serviço de Gastrenterologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital Beatriz Angelo
PT10002: Serviço de Gastrenterologia, Avenida Carlos Teixeira No 3, 2674-514, Loures
Centro Hospitalar Universitario Do Algarve E.P.E.
PT10006: Serviço de Gastroenterologia - Exames Especiais, Sitio Do Poco Seco, 8500-338, Portimao
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
PT10007: Serviço de Gastrenterologia, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
Unidade Local De Saude De Santa Maria E.P.E.
PT10003: Serviço de Gastrenterologia, Avenida Professor Egas Moniz, 1649-035, Lisbon

Slovakia

4 sites · Ongoing, recruitment ended
Cliniq s.r.o.
SK10004: Gastroenterologicka ambulancia, Bezrucova 5, Stare Mesto, Bratislava
Gastro I s.r.o.
SK10003: Gastroenterologicka ambulancia, Puskinova 18, 080 01, Presov
Endomed s.r.o.
SK10002: Gastroenterologicka ambulancia, Americka Trieda 17, Poliklinika Tahanovce, Kosice
F D Roosevelt University General Hospital Of Banska Bystrica
SK10001: II. Interna klinika, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica

Slovenia

1 site · Ongoing, recruitment ended
University Medical Center Ljubljana
SI10002: Gastroenterology, Japljeva Ulica 2, 1000, Ljubljana

Spain

8 sites · Ongoing, recruitment ended
Hospital Universitario De Navarra
ES10003: Gastroenterology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario La Paz
ES10011: Gastroenterology, Paseo De La Castellana 261, 28046, Madrid
Hospital Clinic De Barcelona
ES10007: Gastroenterology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
ES10002: Aparato Digestivo, Avenida Valdecilla Sn, 39008, Santander
Complexo Hospitalario Universitario De Pontevedra
ES10001: Gastroenterologia, Calle Mourente S/n, 36164, Pontevedra
Complexo Hospitalario Universitario De Vigo
ES10010: Gastroenterology, Estrada Clara Campoamor N 341, 36312, Vigo
Parc Tauli Hospital Universitari
ES10009: Aparato Digestivo, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitario De Torrejon
ES10005: Gastroenterologia, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz

Sweden

3 sites · Ended
Karolinska University Hospital
SE10001, Eugeniavagen 3, 171 64, Solna
Linkoping University Hospital Region Ostergotland
SE10002, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Ersta Sjukhus-Ersta Hospital
SE10004, Fjallgatan 44, Sofia, Stockholm

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-08-03 2023-08-10 2024-03-27
Belgium 2023-05-03 2024-01-15 2024-04-16
Bulgaria 2023-04-05 2023-05-17 2024-02-05
Croatia 2023-05-24 2023-06-28 2024-04-02
Czechia 2023-02-03 2023-05-15 2023-09-18
Denmark 2023-04-25 2024-10-16 2023-06-26 2024-01-30
Estonia 2023-05-17 2024-05-30 2023-08-04 2023-09-18
France 2023-04-11 2023-04-11 2024-04-16
Germany 2023-03-17 2023-03-23 2024-04-16
Greece 2023-06-29 2023-06-30 2024-02-14
Hungary 2022-11-30 2023-01-10 2023-07-10
Italy 2023-03-14 2023-03-27 2024-04-16
Netherlands 2023-03-28 2023-07-26 2023-12-19
Norway 2023-06-15 2023-07-12 2024-02-21
Poland 2023-03-10 2023-03-15 2024-04-16
Portugal 2023-08-31 2023-12-18 2024-04-16
Slovakia 2023-03-22 2023-03-23 2024-03-05
Slovenia 2023-05-31 2023-12-06 2023-12-06
Spain 2022-12-29 2023-02-09 2024-04-15
Sweden 2023-05-11 2024-01-31 2024-01-31 2024-01-31

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 295 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Amendment Main English 78934804UCO2001 Public 4.0
Protocol (for publication) D1_Protocol Amendment Main Greek 78934804UCO2001 Public 4.0
Protocol (for publication) D1_Transparency Placeholder for Trademarked Patient Facing Materials 78934804UCO2001 NA
Protocol (for publication) D4_AUT Subject Diary Mayo Daily Diary German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_AUT Subject Questionnaire PGIC German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_AUT Subject Questionnaire UC-PRO SS German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_AUT Subject Questionnaire WPAI-GH German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire Mayo Diary Plain Text Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire Mayo Diary Plain Text French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire Mayo Diary Screen Report Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire Mayo Diary Screen Report French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIC Plain Text Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIC Plain Text French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIC Screen Report Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIC Screen Report French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIS Plain Text Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIS Plain Text French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIS Screen Report Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PGIS Screen Report French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PRO SS Plain Text Dutch 78934804UCO2001 Public 7.0
Protocol (for publication) D4_BEL Subject Questionnaire PRO SS Plain Text French 78934804UCO2001 Public 7.0
Protocol (for publication) D4_BEL Subject Questionnaire PRO SS Screen Report Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire PRO SS Screen Report French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire WPAI-GH Plain Text Dutch 78934804UCO2001 Public 2.2
Protocol (for publication) D4_BEL Subject Questionnaire WPAI-GH Plain Text French 78934804UCO2001 Public 2.2
Protocol (for publication) D4_BEL Subject Questionnaire WPAI-GH Screen Report Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BEL Subject Questionnaire WPAI-GH Screen Report French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BGR Subject Diary Mayo Daily Diary Bulgarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BGR Subject Questionnaire PGIC Bulgarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BGR Subject Questionnaire UC-PRO SS Bulgarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_BGR Subject Questionnaire WPAI-GH Bulgarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_CZE Subject Diary Mayo Daily Diary Czech 78934804UCO2001 Public 1.0
Protocol (for publication) D4_CZE Subject Questionnaire PGIC Czech 78934804UCO2001 Public 1.0
Protocol (for publication) D4_CZE Subject Questionnaire PGIS Czech 78934804UCO2001 Public 1.0
Protocol (for publication) D4_CZE Subject Questionnaire UC-PRO SS Czech 78934804UCO2001 Public 1.0
Protocol (for publication) D4_CZE Subject Questionnaire WPAI-GH Czech 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DEU Subject Diary Mayo Diary German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DEU Subject Questionnaire PGIC German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DEU Subject Questionnaire PGIS German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DEU Subject Questionnaire PRO SS German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DEU Subject Questionnaire WPAI-GH German 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DNK Subject Diary Mayo Diary Danish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DNK Subject Questionnaire PGIC Danish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DNK Subject Questionnaire PGIS Danish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DNK Subject Questionnaire PRO SS Danish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_DNK Subject Questionnaire WPAI-GH Danish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire Mayo Diary Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire PGIC Plain Text Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire PGIC Screen Report Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire PGIS Plain Text Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire PGIS Screen Report Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire UC-PRO SS Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ESP Subject Questionnaire WPAI-GH Spanish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_FRA Subject Questionnaire Mayo Daily Diary French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_FRA Subject Questionnaire PGIC French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_FRA Subject Questionnaire PGIS French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_FRA Subject Questionnaire UC-PRO SS French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_FRA Subject Questionnaire WPAI-GH French 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Diary Mayo Daily Diary Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire PGIC Plain Text Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire PGIC Screen Report Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire PGIS Plain Text Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire PGIS Screen Report Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire PRO and SAE Reporting Guide Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire UC PRO SS Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_GRC Subject Questionnaire WPAI-GH Greek 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HRV Subject Diary Mayo Daily Diary Croatian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HRV Subject Questionnaire PGIC Croatian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HRV Subject Questionnaire PGIS Croatian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HRV Subject Questionnaire UC-PRO SS Croatian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HRV Subject Questionnaire WPAI-GH Croatian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HUN Subject Questionnaire Mayo Daily Diary Hungarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HUN Subject Questionnaire PGIC Hungarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HUN Subject Questionnaire PGIS Hungarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HUN Subject Questionnaire UC-PRO SS Hungarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_HUN Subject Questionnaire WPAI-GH Hungarian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Diary Mayo Daily Diary Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire WPAI-GH Italian 78934804UCO2001 Public 2.3
Protocol (for publication) D4_ITA Subject Questionnaire PGIC Plain Text Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire PGIC Screen Report Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire PGIS Plain Text Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire PGIS Screen Report Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire PRO SS Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_ITA Subject Questionnaire UC-PRO SS Italian 78934804UCO2001 Public 7.0
Protocol (for publication) D4_ITA Subject Questionnaire WPAI-GH Screen Report Italian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NLD Subject Diary Mayo Diary Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NLD Subject Questionnaire PGIC Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NLD Subject Questionnaire PGIS Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NLD Subject Questionnaire PRO SS Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NLD Subject Questionnaire WPAI-GH Dutch 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NOR Subject Diary Mayo Daily Diary Norwegian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NOR Subject Questionnaire PGIC Norwegian 78934804UCO2001 Public 2.0
Protocol (for publication) D4_NOR Subject Questionnaire PGIS Norwegian 78934804UCO2001 Public 2.0
Protocol (for publication) D4_NOR Subject Questionnaire UC-PRO SS Norwegian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_NOR Subject Questionnaire WPAI-GH Norwegian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Materials PRO and SAE Reporting Guide Polish 78934804UCO2001 Public 3.0
Protocol (for publication) D4_POL Subject Questionnaire Mayo Diary Plain Text Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire Mayo diary Screen Report Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire PGIC Plain Text Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire PGIC Screen Report Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire PGIS Plain Text Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire PGIS Screen Report Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire PRO SS Plain Text Polish 78934804UCO2001 Public 7.0
Protocol (for publication) D4_POL Subject Questionnaire PRO SS Screen Report Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_POL Subject Questionnaire WPAI-GH Plain Text Polish 78934804UCO2001 Public 2.2
Protocol (for publication) D4_POL Subject Questionnaire WPAI-GH Screen Report Polish 78934804UCO2001 Public 1.0
Protocol (for publication) D4_PRT Subject Diary Mayo Daily Diary Portuguese 78934804UCO2001 Public 1.0
Protocol (for publication) D4_PRT Subject Questionnaire PGIC Portuguese 78934804UCO2001 Public 1.0
Protocol (for publication) D4_PRT Subject Questionnaire PGIS Portuguese 78934804UCO2001 Public 1.0
Protocol (for publication) D4_PRT Subject Questionnaire PRO SS Portuguese 78934804UCO2001 Public 1.0
Protocol (for publication) D4_PRT Subject Questionnaire WPAI-GH Portuguese 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVK Subject Diary Mayo Diary Slovak 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVK Subject Questionnaire PGIC Slovak 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVK Subject Questionnaire PGIS Slovak 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVK Subject Questionnaire PRO SS Slovak 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVK Subject Questionnaire WPAI-GH Slovak 78934804UCO2001 Public 2.0
Protocol (for publication) D4_SVN Subject Diary Mayo diary Plain Text Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Diary Mayo Diary Screen Report Slovenian 78934804UCO2001 Public 2.0
Protocol (for publication) D4_SVN Subject Questionnaire PGIC Plain Text Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Questionnaire PGIC Screen Report Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Questionnaire PGIS Plain Text Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Questionnaire PGIS Screen Report Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Questionnaire PRO SS Plain Text Slovenian 78934804UCO2001 Public 7.0
Protocol (for publication) D4_SVN Subject Questionnaire PRO SS Screen Report Slovenian 78934804UCO2001 Public 1.0
Protocol (for publication) D4_SVN Subject Questionnaire WPAI-GH Plain Text Slovenian 78934804UCO2001 Public 2.1
Protocol (for publication) D4_SVN Subject Questionnaire WPAI-GH Screen Report Slovenian 78934804UCO2001 Public 1.0
Recruitment arrangements (for publication) K1_AUT Note to File clarifying recruitment materials procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_BGR Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_DEU Note to File clarifying recruitment materials procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_DNK IRB-IEC Filenote 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_ESP Note to File Clarifying Recruitment Materials Procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_FRA Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_GRC IRB-IEC Filenote 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_GRC Note to File Clarifying Recruitment Materials Procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_HRV Note to File Clarifying Recruitment Materials Procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_HUN Note to File clarifying recruitment materials procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_IRB-IEC Filenote 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_IRB-IEC Filenote 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_IRB-IEC Filenote English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_NDL Note to File clarifying recruitment materials procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_NOR Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_POL Note to File clarifying recruitment materials procedure 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_Study Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_SVK Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Recruitment arrangements (for publication) K1_SVN Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Subject information and informed consent form (for publication) K1_Study Note to File Clarifying Recruitment Materials Procedure English 78934804UCO2001 NA
Subject information and informed consent form (for publication) L1_AUT Contact Data Form for site-specific Data English 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_AUT Country ICF Addendum Adult German 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_AUT Country ICF Adult Pregnant Partner German 78934804UCO2001 Public 1.3
Subject information and informed consent form (for publication) L1_AUT Country ICF Adult Withdrawal German 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_AUT Country ICF Genetic Research Adult German 78934804UCO2001 Public 1.3
Subject information and informed consent form (for publication) L1_AUT Country ICF Main Adult German 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Genetic Research Dutch 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Genetic Research English 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Genetic Research French 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Main Dutch 78934804UCO2001 Public 3.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Main English 78934804UCO2001 Public 3.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Main French 78934804UCO2001 Public 3.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Pregnant Partner Dutch 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Pregnant Partner English 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Pregnant Partner French 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_BEL Country ICF Scout Addendum Dutch 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Scout Addendum English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Scout Addendum French 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Withdrawal Dutch 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Withdrawal English 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BEL Country ICF Withdrawal French 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Addendum Bulgarian 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Addendum English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Genetic Research Bulgarian 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Genetic Research English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Main Bulgarian 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Main English 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Pregnant Partner Bulgarian 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Pregnant Partner English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Withdrawal Bulgarian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Withdrawal English 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Addendum Czech 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Genetic Research Czech 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult Already enrolled Czech 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Czech 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Pregnant Partner Czech 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Scout Czech 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Withdrawal Czech 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Privacy Czech 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_CZE Country ICF Research Czech 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_CZE Subject Participation Card Czech 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_DEU ICF Addendum German 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_DEU ICF Extension Adult German 78934804UCO2001 Public 2.1
Subject information and informed consent form (for publication) L1_DEU ICF Future Research German 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_DEU ICF Optional Genetic Research German 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_DEU ICF Pregnant Partner German 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_DEU ICF Withdrawal German 78934804UCO2001 Public 2.1
Subject information and informed consent form (for publication) L1_DEU Main ICF German 78934804UCO2001 Public 3.1
Subject information and informed consent form (for publication) L1_DNK Country ICF Genetic Research Danish 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_DNK Country ICF Main Danish 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_DNK Country ICF Other Pregnant Partner Danish 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_DNK Country ICF Other Withdrawl Danish 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_ESP Country ICF Addendum Spanish 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_ESP Country ICF Genetic Research Spanish 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_ESP Country ICF Main Spanish 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_ESP Pregnant Partner ICF Spanish 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_ESP Withdrawal ICF Spanish 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Genetic Research French 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Main French 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Pregnant Partner French 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Withdrawal French 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Addendum English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Addendum Greek 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Genetic Research Adult English 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Genetic Research Adult Greek 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Main English 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Main Greek 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Pregnant Partner English 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Pregnant partner Greek 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Research Adult Greek 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Withdrawal English 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Withdrawal Greek 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Addendum Croatian 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Genetic Research Croatian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Main Croatian 78934804UCO2001 Public 3.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Research Croatian 78934804UCO2001 Public 1.0
Subject information and informed consent form (for publication) L1_HRV Country Pregnant Participant ICF Croatian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HRV Country Pregnant Partner ICF Croatian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HRV Country Withdrawal ICF Croatian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Genetic Research Hungarian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Genetic Research PIS Hungarian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Main Hungarian 78934804UCO2001 Public 3.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Optional Research ICF Hungarian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Optional Research PIS Hungarian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Pregnant Partner ICF Hungarian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Pregnant Partner IS Hungarian 78934804UCO2001 Public 1.1
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Withdrawal ICF Hungarian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF Other Withdrawal PIS Hungarian 78934804UCO2001 Public 2.0
Subject information and informed consent form (for publication) L1_HUN Country ICF_Main Hungarian 78934804UCO2001 Public 4.0
Subject information and informed consent form (for publication) L1_HUN Subject Participation Card_Justification letter English 78934804UCO2001 Public 1.0
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Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Bulgarian 78934804UCO2001 Public 4.0
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Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-04-15 Netherlands Acceptable
2024-05-22
 2024-05-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-09-10 Acceptable
2024-05-22
 2024-09-10
3 SUBSTANTIAL MODIFICATION SM-1 2024-11-27 Netherlands Acceptable
2025-03-17
 2025-03-17
4 SUBSTANTIAL MODIFICATION SM-2 2025-03-25 Acceptable 2025-03-26
5 SUBSTANTIAL MODIFICATION SM-3 2025-07-04 Netherlands Acceptable
2025-09-08
 2025-09-08
6 SUBSTANTIAL MODIFICATION SM-4 2025-10-29 Netherlands Acceptable
2026-01-14
 2026-01-14
7 NON SUBSTANTIAL MODIFICATION NSM-3 2026-01-26 Netherlands Acceptable
2026-01-14
 2026-01-26

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