Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
378
Countries
9
Sites
59
Chronic Hepatitis B
1. To describe long-term durability of funtional cure in not-on NA complete responders, who achieve FC 2. To describe long-term durability of functional cure following NA cessation in B-Sure, in on-NA complete responders. 3. To describe long-term durability of functional cure in NA-cessated participants who achieved FC…
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 25 Jan 2022 → ongoing
- Decision date (initial)
- 2024-05-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- GlaxoSmithKline Research & Development Limited
External identifiers
- EU CT number
- 2023-506867-33-01
- EudraCT number
- 2021-000554-26
- ClinicalTrials.gov
- NCT04954859
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
1. To describe long-term durability of funtional cure in not-on NA complete responders, who achieve FC
2. To describe long-term durability of functional cure following NA cessation in B-Sure, in on-NA complete responders.
3. To describe long-term durability of functional cure in NA-cessated participants who achieved FC in B-well 1 & 2
Secondary objectives 8
- Efficacy: To describe changes in disease following NA cessation as measured by time to HBsAg loss, time to virologic relapse, time to clinical relapse and time to first use of any rescue medication in on-NA complete responders
- Efficacy: To describe changes in disease following NA cessation, as measured by time to HBsAg reversion, time to virologic relapse, time to clinical relapse and time to first use of any rescue medication in NA-cessated participants.
- Efficacy: To describe long-term durability of treatment response, as measured by time to loss of response in on-NA participants who achieved a response, and are continuing NA treatment
- Efficacy: To describe: a. achieving delayed FC in B-Sure in not-on-NA participants who achieved a partial response in B-Clear b. time to loss of FC in participants achieving delayed FC
- Efficacy: To describe a. achieving delayed FC in B-Sure, in NA-cessated participants who did not achieve FC in B-Well b. time to loss of FC in participants achieving delayed FC
- Efficacy: To describe a. achieving delayed FC in B-Sure, in on-NA participants, who achieved a partial response in the parent study and discontinued NA treatment in B-Sure b. time to loss of FC in participants achieving delayed FC.
- Efficacy: To describe: a. achieving delayed complete response in BSure, in on-NA participants, who achieved a partial response in the parent study and did not discontinue NA treatment in B-Sure b. time to loss of response in participants achieving delayed treatment response
- Efficacy: To describe changes in disease after NA cessation in B-Sure as measured by time to HBsAg loss, time to virologic relapse, time to clinical relapse and time to first use of any rescue medication in on-NA participants who achieved a partial response in the parent study and discontinue NA treatment in B-Sure
Conditions and MedDRA coding
Chronic Hepatitis B
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- IPD for this study will be made available via the Clinical Study Data Request site.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504238-23-00 | Phase 3 Multicenter, Randomized, Double Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg negative Nucleos(t)ide Analogue treated Participants with Chronic Hepatitis B Virus (B Well 2) | Glaxosmithkline Research & Development Limited |
| 2020-002000-39 | B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping | |
| 2020-002979-35 | A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment with GSK3228836 followed by Pegylated Interferon Alpha 2a in Participants with Chronic Hepatitis B Virus (B-Together), Studio multicentrico di fase IIb, randomizzato, in aperto, per valutare l’efficacia e la sicurezza del trattamento sequenziale con GSK3228836 seguito da interferone alfa-2a pegilato in partecipanti con infezione cronica da virus dell’epatite B (B-Together) | |
| 2023-504239-41-00 | Phase 3 Multicenter, Randomized, Double Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg negative Nucleos(t)ide Analogue treated Participants with Chronic Hepatitis B Virus (B Well 1) | Glaxosmithkline Research & Development Limited |
| 2020-001083-29 | Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment with GSK3228836 in Participants with Chronic Hepatitis B Virus (B-Clear), Randomizowane, wieloośrodkowe, częściowo zaślepione badanie kohortowe fazy IIb prowadzone w grupach równoległych, oceniające skuteczność i bezpieczeństwo leczenia preparatem GSK3228836 u pacjentów z przewlekłym zakażeniem wirusem zapalenia wątroby typ u B (B-Clear). , Randomizowane, wieloośrodkowe, częściowo zaślepione badanie kohortowe fazy IIb prowadzone w grupach równoległych, oceniające skuteczność i bezpieczeństwo leczenia preparatem GSK3228836 u pacjentów z przewlekłym zakażeniem wirusem zapalenia wątroby typ u B (B-Clear). , Estudio fase IIb, aleatorizado, multicéntrico, de grupos paralelos, parcialmente ciego (promotor y participante ciegos, equipo investigador no ciego) para evaluar la eficacia y seguridad del tratamiento con GSK3228836 en sujetos con Hepatitis B crónica. (B-Clear), Studio multicentrico di fase IIb, randomizzato, in cieco parziale, a coorti parallele, per valutare l’efficacia e la sicurezza del trattamento con GSK3228836 in partecipanti con infezione cronica da virus dell’epatite B (B-Clear), Studio multicentrico di fase IIb, randomizzato, in cieco parziale, a coorti parallele, per valutare l’efficacia e la sicurezza del trattamento con GSK3228836 in partecipanti con infezione cronica da virus dell’epatite B (B-Clear) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule
- 2. Capable of giving informed consent
- 209668 (B-Clear), 209348 (B-Together) and 212602 (B-Fine) participants: 3. Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved a complete response in the parent study and who maintained a response for 24 weeks until the EoS visit in their parent study, in the absence of rescue medication (defined as complete responders to bepirovirsen from the parent study) OR b. Demonstrated HBsAg reduction from parent study Baseline with HBsAg levels and HBV DNA for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
- 202009 and 219288 (B-Well 1 & 2) participants: 4. Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where approrpiate) AND a. NA cessated at Week 48 in parent study and achieved HBsAg and HBV DNA, in the absence of rescue medication at the EOS visit (Week 96) in the parent study OR b. Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining HBsAg and HBV DNA at EOS visit (Week 72) of parent study OR c. Did not achieve NA cessation criteria in parent study, but achieved HBsAg and HBV DNA at EOS visit (Week 72) of parent study
- 217023 (TH HBV ASO-001) participants: 5. Participants who have previously received at least 1 dose of bepirovirsen AND achieved HBsAg and HBV DNA at the EOS study visit in parent study
Exclusion criteria 2
- 1. Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
- 2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- For 209668 (B-Clear; not-on-NA): Time from achieving FC, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA)and 217023 (TH HBV ASO-001; on-NA): Time from achieving FC (24 weeks post NA cessation) to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication
- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from achieving FC (including delayed FC) in the parent study to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.
Secondary endpoints 16
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): • Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first use of rescue medication
- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication. Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication.
- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication. Time from NA cessation to first use of any rescue medication.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA): • Time from achieving complete response in the previous bepirovirsen treatment study, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication
- 202009 and 219288 (B-Well 1 & 2; On-NA) and 217023 (TH HBV ASO-001; on-NA): •Time from HBsAg and HBV DNA , to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.
- For 209668 (B-Clear; not-on-NA) partial responders: a. Time from end of treatment in the parent study to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC.
- For 202009 and 219288 (B-Well 1 & 2; NA-cessated) partial responders: a. Time from NA cessation to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1&2; on-NA), and 217023 (TH HBV ASO-001; on-NA): a. Time from NA cessation in B-Sure to delayed FC in B-Sure. b. For participants who achieve delayed FC in B-Sure: Time from achieving delayed FC to loss of FC.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1&2; on-NA): a.Time from end of treatment in the parent study to delayed complete response. b. For participants who achieve a delayed complete response: Time from achieving delayed complete response to loss of response.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to HBsAg loss in the absence of any rescue medication.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication.
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication
- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first use of rescue medication.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7999023 · Product
- Active substance
- Bepirovirsen
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GCK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GCK Clinical Trials Call Center
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Other, Laboratory analysis |
| Illingworth Research Group Limited ORG-100042356
|
Macclesfield, United Kingdom | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Code 10 |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 12, E-data capture, Code 8 |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, E-data capture, Code 8 |
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Sponsor responsibilities
- Article 77 compliance
- Glaxosmithkline Research & Development Limited
- Contact point sponsor
- Glaxosmithkline Research & Development Limited
- Article 77 implementation
- Glaxosmithkline Research & Development Limited
Locations
9 EU/EEA countries · 59 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 15 | 6 |
| France | Ongoing, recruitment ended | 14 | 7 |
| Germany | Ongoing, recruitment ended | 11 | 6 |
| Greece | Ongoing, recruitment ended | 7 | 4 |
| Hungary | Ongoing, recruitment ended | 1 | 1 |
| Italy | Ongoing, recruitment ended | 13 | 9 |
| Poland | Ongoing, recruitment ended | 13 | 5 |
| Romania | Ongoing, recruitment ended | 14 | 8 |
| Spain | Ongoing, recruitment ended | 20 | 13 |
| Rest of world
Panama, Philippines, Brazil, United Kingdom, Thailand, Turkey, Canada, Australia, Hong Kong, Malaysia, China, Argentina, Japan, Taiwan, Korea, Republic of, South Africa, India, Singapore, Russian Federation, United States, New Zealand
|
— | 270 | — |
Investigational sites
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Clinic of Internal Medicine, Bulevard D-R G.m.dimitrov 16, 1797, Sofiya
Military Medical Academy
Gastroenterology Clinic, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Diagnostics-Consultancy Center Mladost M Varna OOD
NA, Bulevard Republika 15, 9020, Varna
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Gastroenterology Clinic, Bulevard Peshtersko Shose 66, 4002, Plovdiv
Diagnostic-Consultative Center Alexandrovska EOOD
NA, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department of Internal Medicine, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Assistance Publique Hopitaux De Paris
Service Hepato-gastro-enterologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Bordeaux
Service Hepato-gastro-enterologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Rennes
Liver Disease department, 2 Rue Henri Le Guilloux, 35000, Rennes
Les Hopitaux Universitaires De Strasbourg
Service Hepato-gastro-enterologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Intercommunal Creteil
Service Hepato-gastroenterologie, 40 Avenue De Verdun, 94000, Creteil
Hospices Civils De Lyon
Service d hepatologie et gastroenterologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Assistance Publique Hopitaux De Paris
Service d hepatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Universitaetsklinikum Duesseldorf AöR
Klinik fuer Gastroenterologie, Hepatologie und Infektiologie, Moorenstrasse 5, Bilk, Duesseldorf
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
NA, Budapester Strasse 15-19, Tiergarten, Berlin
Infektiologisches Zentrum Steglitz (IZS)
NA, Schloßstr. 88, 12163, Berlin
ICH Study Center GmbH & Co. KG
Rotherbaum, Grindelallee 35, Rotherbaum, Hamburg
Praxis MainFachArzt
HIV- und infektiologische Schwerpunktpraxis, Kaiserstrasse 42, 60329, Frankfurt
Medizinische Hochschule Hannover
Klinik fuer Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Hippokration Hospital
2nd University Internal Medicine Clinic/ Hepogastrenterology Unit, Vassilissas Sofias Avenue 114, 115 27, Athens
Evaggelismos Hospital
3rd Internal Medicine Department, Ipsiladou 45-47, 106 76, Athens
Laiko General Hospital Of Athens
1st Department of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Infektologia - Felnott rendelo, Albert Florian Ut 5-7, 1097, Budapest IX
Azienda Ospedaliero Universitaria Pisana
Epatologia, Via Paradisa 2, 56124, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Gastroenterology and Hepatology Division, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC Gastroenterologia, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero Universitaria Di Modena
Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale, Via Pietro Giardini 1355, 41126, Modena
ASST Fatebenefratelli Sacco
Department of Infectious Diseases, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
SC Malattie Infettive, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SC Gastroenterologia U, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
INFECTIOUS DISEASES, Via Sergio Pansini 5, 80131, Naples
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Dipartimento di Medicina, SC di Gastroenterologia 1 Epatologia Trapiantologia, Piazza Oms 1, 24127, Bergamo
ID Clinic
N/A, Ul. Janowska 19, 41-400, Myslowice
Centrum Medyczne W Lancucie Sp. z o.o.
N/A, Ul. Ignacego Paderewskiego 5, 37-100, Lancut
Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
N/A, Ul. Jana Kochanowskiego 114, 80-405, Gdansk
HEPID Diagnostyka i Terapia
N/A, Milenijna 12C, 20-884, Lublin
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Hepatology Department, Ul. Pradnicka 80, 31-202, Cracow
Pelican Impex S.R.L.
Gastroenterologie, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
N/A, Strada Dr. Calistrat Grozovici Nr. 1, 021105, Bucharest
Spitalul Clinic Colentina Bucuresti
Gastroenterologie, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Boli Infecțioase si tropicale, Soseaua Mihai Bravu Nr 281 Sector 3, 030303, Bucharest
Clinic Hospital For Infectious Diseases Sf. Cuvioasa Parascheva Galati
Infectious Diseases Clinic Section I, Traian Street No 393, 800179, Galati
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Sectia Clinica II Boli Infectioase Adulti, Strada Dr. Calistrat Grozovici Nr. 1, 021105, Bucharest
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
Clinica de Boli Infectioase Adulti II, 126 Calea Bucuresti, 200446, Craiova
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Sectia I, Strada Botez Octav Nr 2, 700116, Jassi
Hospital Universitario 12 De Octubre
Gastroenterology Service, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Y Politecnico La Fe
Digestive Medicine - Hepatology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Marques De Valdecilla
Digestive Department, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Infanta Leonor
Internal Medicine, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario De Salamanca
Internal Medicine, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
Digestive and Liver Diseases, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De La Princesa
Gastroenterology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinic De Barcelona
Hepatology, Calle Villarroel 170, 08036, Barcelona
Parc Tauli Hospital Universitari
Gastroenterology, Parc Del Tauli 1, 08208, Sabadell
University Hospital Virgen Del Rocio S.L.
Gastroenterology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Leon
Digestive, Calle Altos De Nava S/n, 24071, Leon
Complexo Hospitalario Universitario De Pontevedra
Hepathology, Calle Mourente S/n, 36164, Pontevedra
Consorcio Hospital General Universitario De Valencia
Digestive, Avenida Tres Cruces 2, 46014, Valencia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2022-01-27 | 2022-02-02 | 2026-04-23 | ||
| France | 2025-11-03 | 2025-11-03 | 2026-04-23 | ||
| Germany | 2025-03-14 | 2025-03-17 | 2026-04-23 | ||
| Greece | 2025-10-08 | 2025-10-21 | 2026-04-23 | ||
| Hungary | 2025-09-29 | 2025-10-07 | 2026-04-23 | ||
| Italy | 2022-01-25 | 2022-01-26 | 2026-04-23 | ||
| Poland | 2022-04-26 | 2022-12-27 | 2026-04-23 | ||
| Romania | 2022-02-22 | 2022-02-25 | 2026-04-23 | ||
| Spain | 2022-07-22 | 2022-11-03 | 2026-04-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-05-23
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with CTR Q&A / point 1.23, the sponsor is asked to submit a substantial modification application in order to update the CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 74 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506867-33-01_GR_redacted | Amend 4 |
| Protocol (for publication) | D1_Protocol 2023-506867-33-01_redacted | Amend 4 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_FR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements flipchart_Redacted | 2.1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements patient brochure | 4.1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements patient newsletter | 2.1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_template | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_flipchart_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_flowchart_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GP Letter_BG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GP Letter_ENG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient brochure_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient newslett_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PatientGO App_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PatientGO EULA_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PatientGO Info Sheet_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PatientGO Privacy Policy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future researches_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main EN_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main RO_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 01.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 01.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FR_Redacted | 5.5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_redacted | 01.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_Redacted | 01.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_252776_BG_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_252777_BG_Redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ENG_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_Redacted | 5.4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO SupplementalICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SPA_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-3L_BG | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-3L_IT | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-3L_PL | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EQ-5D-3L-GR | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBQoL_BG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBQoL_GR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBQoL_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBQoL_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participation Card_BG | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participation Card_ENG | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientGO App_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_questionnaire EQ-5D-3L_RO | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_questionnaire_EQ-5D-3L | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_questionnaire_HBQoL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_questionnaire_HBQoL_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Support information_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_GP letter_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_GP letter_ROU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Participation Card | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Participation Card_ROU | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_ 2023-506867-33-01_redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-506867-33-01_redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-506867-33-01_Redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR_2023-506867-33-01_redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2023-506867-33-01_redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-506867-33-01_Redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-506867-33-01_redacted | Amend 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2023-506867-33-01_Redacted | Amend 4 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-07 | Spain | Acceptable 2024-02-28
|
2024-02-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-18 | Spain | Acceptable 2024-09-11
|
2024-09-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-23 | Acceptable 2024-09-11
|
2024-10-23 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-11-05 | 2025-02-17 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-12-12 | Acceptable 2024-09-11
|
2025-03-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-21 | Acceptable | 2025-03-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-29 | 2025-03-31 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-30 | Spain | Acceptable | 2025-02-13 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-10 | Acceptable | 2025-04-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-28 | Spain | Acceptable | 2025-04-08 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-31 | Acceptable | 2025-04-30 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-05-29 | Spain | Acceptable 2025-07-31
|
2025-07-31 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-12-17 | Acceptable | 2026-02-03 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-23 | Spain | Acceptable | 2026-04-23 |