Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
81
Countries
11
Sites
50
Homeostatic iron regulator gene-related hereditary hemochromatosis
To assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH).
Key facts
- Sponsor
- CSL Behring LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Decision date (initial)
- 2026-04-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CSL Behring
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with homeostatic iron
regulator gene-related hereditary hemochromatosis (HFE-HH).
Secondary objectives 1
- To assess the safety and tolerability of vamifeport
Conditions and MedDRA coding
Homeostatic iron regulator gene-related hereditary hemochromatosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10057873 | Hereditary haemochromatosis | 100000004850 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Overall Study This is multicenter, randomized, placebo-controlled double-blind, parallel-group study.
|
Randomised Controlled | Double | [{"id":180655,"code":5,"name":"Carer"},{"id":180656,"code":2,"name":"Investigator"},{"id":180652,"code":3,"name":"Monitor"},{"id":180654,"code":4,"name":"Analyst"},{"id":180653,"code":1,"name":"Subject"}] | Vamifeport Low Dose: Participants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360. Vamifeport High Dose: Participants will receive a high dose of vamifeport orally, BID up to Day 360. Placebo: Participants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360. |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Adult (≥ 18 years) and has provided written informed consent.
- 2. Confirmed diagnosis of HFE-HH in medical history.
- 3. Evidence of iron overload as shown by: • TSAT > 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and • Serum ferritin ≥ 200 ng/mL and < 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and • MRI-based LIC between 3 and 16 mg/g (53.7 and 286.5 mmol/kg) dry weight (dw) at Screening.
- 4. Body mass index between 18.5 and 32 kilograms per meter squared (kg/m^2).
Exclusion criteria 1
- 1. Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12988397 · Product
- Active substance
- Vamifeport Trihydrochloride
- Substance synonyms
- Vamifeport hydrochloride, 2-(2-{[2-(1H-benzimidazol-2-yl)ethyl]amino}ethyl)-N-[(3-fluoropyridin-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride, VIT-2763 trihydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 360 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CSL BEHRING LLC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Capsule (placebo matching vamifeport)
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
CSL Behring LLC
- Sponsor organisation
- CSL Behring LLC
- Address
- 1020 1st Avenue
- City
- King Of Prussia
- Postcode
- 19406-1310
- Country
- United States
Scientific contact point
- Organisation
- CSL Behring LLC
- Contact name
- Study Director
Public contact point
- Organisation
- CSL Behring LLC
- Contact name
- Trial Registration Coordinator
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Resonance Health Analysis Services Pty Limited ORG-100049843
|
Burswood, Australia | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Other, Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| PPD (UK) Limited ORG-100022673
|
Cambridge, United Kingdom | On site monitoring, Code 11, Code 12, Other, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8 |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Code 14 |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Other |
| Longboat Clinical Limited ORG-100045828
|
Limerick, Ireland | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| CSL Innovation Pty Limited ORG-100051289
|
Melbourne, Australia | Other |
Locations
11 EU/EEA countries · 50 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 3 | 3 |
| Belgium | Authorised, recruitment pending | 5 | 5 |
| Czechia | Authorised, recruitment pending | 3 | 3 |
| France | Authorised, recruitment pending | 9 | 10 |
| Germany | Authorised, recruitment pending | 3 | 4 |
| Ireland | Authorised, recruitment pending | 4 | 3 |
| Italy | Authorised, recruitment pending | 6 | 6 |
| Netherlands | Authorised, recruitment pending | 2 | 1 |
| Poland | Authorised, recruitment pending | 3 | 3 |
| Romania | Authorised, recruitment pending | 5 | 5 |
| Spain | Authorised, recruitment pending | 7 | 7 |
| Rest of world
United Kingdom, United States, Switzerland, Australia, New Zealand, Canada
|
— | 31 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Universitaetsklinik für Innere Medizin I, Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Abteilung für Innere Medizin III Gastroenterologie und Hepatologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Abteilung Interne IV, Seilerstaette 4, 4010, Linz
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Universitair Ziekenhuis Gent
Gastro-enterology, Corneel Heymanslaan 10, 9000, Gent
UZ Brussel
Gastro-enterology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Antwerpen
Gastro-enterology & Hepatology, Drie Eikenstraat 655, 2650, Edegem
Centre hospitalier universitaire de Liege
Hematology, Avenue De L'Hopital 1, 4000, Liege
Institute For Clinical And Experimental Medicine
Klinika hepatogastroenterologie, Videnska 1958/9, Krc, Prague
Fakultni Nemocnice Ostrava
Interní a kardiologická klinika, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Oddělení klinické hematologie, Jihlavska 340/20, Bohunice, Brno
Centre Hospitalier Et Universitaire De Limoges
Hepato-Gastro-Enterology department, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Regional De Marseille
Hepatology department, 264 Rue Saint Pierre, 13005, Marseille
Hospices Civils De Lyon
lnternal Medicine and Vascular Pathology department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
CHU Saint Eloi - Hopital Saint Eloi
Hepato-gastro-enterology department, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5 France
Centre Hospitalier Universitaire De Rennes
Liver disease department, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier De Saint-Brieuc
Gastroenterology and hepatology department, 10 Rue Marcel Proust, 22000, Saint-Brieuc
Centre Hospitalier Universitaire De Toulouse
Hepatology department, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Digestive Oncology department, Avenue De Magellan, 33600, Pessac
Hopital Paul Brousse
Gastro-enterology and Hepatology department, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Assistance Publique Hopitaux De Paris
Hepatology department, 125 Rue De Stalingrad, 93000, Bobigny
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
ze:ro Praxen MVZ fuer Innere Medizin GmbH
Ze:ro Praxen MVZ der Metropolregion GmbH & Co. eGbR, Bergstrasse 49, 69469, Weinheim
Eugastro GmbH
eugastro GmbH, Johannisplatz 1, Zentrum Sudost, Leipzig
Medical Center - University Of Freiburg
Studienambulanz Rheumatologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Cork University Hospital
hepatology, Wilton, T12 DC4A, Cork
Connolly Hospital
Gastroenterologist, Mill Road, D15 X40D, Dublin 15
Beaumont Hospital
Gastroenterology and Hepatology, Beaumont Road, Beaumont, Dublin 9
Azienda Ospedaliero Universitaria Di Modena
S.C. Medicina Interna, Largo Del Pozzo 71, 41124, Modena
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
: U.O. Medicina Interna e Malattie Metaboliche, Via Francesco Sforza 35, 20122, Milan
Azienda Sanitaria Locale Br
U.O.C. Ematologia e Trapianto, Via Napoli 8, 72100, Brindisi
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
U.O.S.D. Malattie Rare del Globulo Rosso Dipartimento Onco-ematologico e Pneumo-toracico, Via Antonio Cardarelli 9, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
SSD Malattie Rare, Via Giovanbattista Pergolesi 33, 20900, Monza
Centro Ricerche Cliniche Di Verona S.r.l.
Policlinico GB Rossi di Borgo Roma, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Radboud universitair medisch centrum Stichting
Internal Medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddział Hematologiczny, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Instytut Hematologii I Transfuzjologii
N/A, Ul. Indiry Gandhi 14, 02-776, Warsaw
Provincial Specialist Hospital Them. J. Gromkowski
N/A, Ul. Koszarowa 5, 51-149, Wroclaw
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Sectia Oncologie Medicala Compartiment Hematologie, 149th Ic Bratianu Street, 077015, Balotesti
Spitalul Clinic Judetean de Urgenta Bistrita
Sectia Oncologie Medicala, Str. Ghinzii 26, 420020, Bistrita
Spitalul Clinic Coltea
Clinica de Hematologie, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Sectia Hematologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Sectia Clinica Medicina Interna, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Institut Catala D'oncologia
Haematology, Carretera Canyet S/n, 08916, Badalona
University Hospital Virgen Del Rocio S.L.
Haematology and Haemotherapy, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario La Paz
Haematology and Haemotherapy, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Gastroenterology and Hepatolgy, Calle De Manuel De Falla 1, 28222, Majadahonda
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Haematology and Haemotherapy, Carrer Del Doctor Joan Soler 1-3, 08243, Manresa
Hospital Clinic De Barcelona
Blood Bank and Transfusion Service BST- Clinic, Calle Villarroel 170, 08036, Barcelona
El Hospital Universitario De Gran Canaria Dr. Negrin
Haematology and Haemotherapy, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 367 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_CSL Behring_CSL624_2001_Protocol_2025-523793-16-00_Public | Amd 2 |
| Protocol (for publication) | D4_CSL Behring_CSL624_2001_Questionnaire EQ5D5L_eCOA_ENG_Public | 1 |
| Protocol (for publication) | D4_CSL Behring_CSL624_2001_Questionnaire_Statement Reg Publication_Public | n/a |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Addendum-to-Informedconsent_Patientrecruitmentprocedure_DEU | 1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_AUTOCALL OUTBOUND_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Banners_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Comfort items_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_DIRECT MAIL_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Doctor Letter_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_EMAIL_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Email_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Flipchart_IRL_ENG_Public | 1.2 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Flyer_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Images_MASTER_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Informedconsent_Patientrecruitmentprocedure_DEU | 1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Landing Page_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_LandingPage_IE_ENG_Public | 1.2 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_LONG LIVE DIAL SCRIPT_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_MOBILE LandingPage_IRL_ENG_Public | 1.2 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_PAG Email_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_PAGKit_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Patient Letter_IRL_ENG_Public | 1.2 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Primary_Screener_Consent_MASTER_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Primary_Screener_MASTER_IRL_ENG_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment Arrangements_BEL_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment Arrangements_IRE_ENG_Public | n/a |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment Brochure_IRL_ENG_Public | 1.2 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment_and_ICF_Procedure_RO-en_Public | 1 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment_Informed_Consent_Procedure_FRA_fra_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-and-Informed-Consent-Procedure_AUT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-and-Informed-Consent-Procedure_ITA_ENG | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-Arrangements_CZE | N/A |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-arrangements_NLD_eng_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-Arrangements_PL_POL_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Recruitment-IC-Procedure_ESP_Public | n/a |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Reengagement_Package_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_SMS_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Social Media Ads_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Social_1080x1080_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Social_1200x628_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Thank You Card_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_URLs_Master_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CSL624_2001_Welcome Guide_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001__LandingPage_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_AUTOCALL-OUTBOUND_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Autocall-Outbound_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Autocall-Outbound_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Autocall-Outbound_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Autocall-Outbound_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_AUTOCALL-OUTBOUND_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_AUTOCALL-OUTBOUND_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_AUTOCALL-OUTBOUND_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_AUTOCALLOUTBOUND_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_AUT_deu_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Banners_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_DIRECT MAIL_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_DIRECT-MAIL_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Direct-Mail_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Direct-Mail_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Direct-Mail_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Direct-Mail_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_DIRECT-MAIL_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_DIRECT-MAIL_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_DIRECT-MAIL_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_EMAIL_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_DE_DE | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_EMAIL_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_EMAIL_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_EMAIL_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email-content_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email-content_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email-content_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Email-content_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_AUT_deu_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_FRA_fra_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flipchart_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_FRA_fra_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Flyer_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_GP-Letter_IRL_ENG_Public_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_CZE_ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_DEU | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_MASTER_AUT_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images_USA_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Images-MASTER_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_KEYWORD SEARCH_IRL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_AUT_deu_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_ITA_ITA__Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Landing-Page-content_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage-content_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage-content_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LandingPage-content_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LL-DIAL-SCRIPT_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LONG LIVE DIAL SCRIPT_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LONG-LIVE-DIAL-SCRIPT_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Long-Live-Dial-Script_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Long-Live-Dial-Script_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Long-Live-Dial-Script_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Long-Live-Dial-Script_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LONG-LIVE-DIAL-SCRIPT_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_LONG-LIVE-DIAL-SCRIPT_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_MOBILE LandingPage_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_MOBILE LandPage_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_MOBILE-Landing-Page_AUT_deu_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Mobile-Landing-Page_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_MOBILE-Landing-Page_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Mobile-LandingPage_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Mobile-LandingPage_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Mobile-LandingPage_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_MOBILE-LandingPage_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG Email_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_FRA_fra_Public | 1.2 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Email_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Kit_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAG-Kit_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_FRA_fra_Public | 1.2 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_PAGKit_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient Letter_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient_Recrutiment_Documents_Table_Summary_IRL_ENG_Clean_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_FRA_fra_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Patient-Letter_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Prim-Screen-Consent_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_Consent_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_Consent_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_Consent_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_Consent_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary_Screener_ESP_SPA_Public | n/a |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener-Consent_AUT_deu_undated_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener-Consent_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener-Consent_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener-Consent-MASTER_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Primary-Screener-MASTER_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Rec Brochure_ESP_SPA_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Brochure_RO-en_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Brochure_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Comfort_Items_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Dr_to_Patient_Letter_RO-en_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Dr_to_Patient_Letter_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Flipchart_RO-en_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Flipchart_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Flyer_RO-en_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Flyer_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Welcome_Guide_RO-en_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment_Welcome_Guide_RO-ro_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_FRA_fra_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Brochure_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Autocall-Outbound_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Banners_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Brochure_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Direct-Mail_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Email__NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Email_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Flipchart_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Flyer_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Landing-Page_NLD__nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Landing-Page_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Long-Live-Dial-Script_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Mob-Landing-Page_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-PAG-Email_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-PAG-Kit_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Patient-Ltr_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Primary-Screener_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Primary-Screener-Consent_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Reengagement-Package_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-SMS_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Social-1080x1080_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Social-1200x628_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-Social-Media-Ads_NLD_nld_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Recruitment-Mat-URLs_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement_Package_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement_Package_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement_Package_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement_Package_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement_Package_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement-Package_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement-Package_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Reengagement-Package_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_SMS_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social Media Ads_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1080x1080_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social_1200x628_ESP_SPA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-1080x1080_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-1200x628_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-1200x628_PL_POL | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_AUT_deu_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_BEL_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_BEL_NLD_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_CZE_CES | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_DEU_deu | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_ITA_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_Social-Media-Ads_PL_POL | 1.1 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_AUT_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_BEL_ENG_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_CZE_ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_DEU | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624_2001_URLs_Master__PL_END | 1.0 |
| Recruitment arrangements (for publication) | K2_CSL624-2001_Reengagem_Pack_ESP_SPA_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_HH Optional Training Module_eCOA Handheld_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_HH Science English_IRL_ENG_Public | n/a |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_HH Training Module_eCOA Handheld_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_Instructions for Taking Your Medication_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_PFD_Email Comm_TR-ERR_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL_624-2001_Study Drug Instructions_IRL_EN_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001__eCOA Handheld_patientConnect_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Adult-ICF_ITA_ITA_Public | 3 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_eCOA Handheld_Alarms_IRL_ENG_Public | 1.00 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_eCOA Handheld_application_dashboard_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_eCOA Handheld_DosingDiaryInstructions_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_eCOA Handheld_EveningDiary_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_eCOA Handheld_MorningDiary_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_GDPR-ICF_CZE_CES_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF_Adult_EU_RO-en_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF_Adult_EU_RO-ro_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF_Pregnant_Partner_EU_RO-en_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF_Pregnant_Partner_EU_RO-ro_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF-Main_PL_POL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_ICF-Pregnant-Partner_PL_POL_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main ICF_BEL_ENG_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main ICF_BEL_FRA_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main ICF_BEL_NLD_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main ICF_ESP_SPA_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main_ICF_FRA_fra_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main-ICF_AUT_deu_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main-ICF_CZE_CES_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main-ICF_DEU_deu_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Main-ICF-IRL_ENG_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Optional Tablet Training Module_eCOA Tablet_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_PFD_Reloadable ScoutPass FAQs_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_PFD_Scout Brochure_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_PP ICF_ESP_SPA_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnancy_ICF_DEU_deu_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnancy-Follow-Up-ICF_AUT_deu_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnancy-Newborn-ICF_FRA_fra_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant Partner ICF_BEL_eng_Clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant Partner ICF_BEL_fra_Clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant Partner ICF_BEL_nld_Clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant Partner-ICF-IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant-Partner-ICF_CZE_CES_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Pregnant-Partner-ICF_ITA_ITA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_SC_PFD_Reloadable ScoutPass Mailer_IRL_ENG_Public | n/a |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_SC_PFD_Taxable Payments Letter_Template_IRL_ENG_EN_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Scout Clinical Tax and KYC Information_IRL_ENG_Public | n/a |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_SIS-and-ICF_Main_NLD_nld_Clean_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_SIS-and-ICF_Pregnancy_NLD_nld_Clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Sponsor Statement Main ICF_BEL_ENG_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Summary_PIS-IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Tablet Training Module_eCOA Tablet_English_IRL_ENG_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_TB Science English_IRL_ENG_Public | n/a |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Tips to help you remember your twice-daily dose_IRL_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CSL624_2001_Use of personal data ICF_ITA_ITA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_CSL624-2001_Optional-future-research_ICF_DEU_deu_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_CSL624_2001_GP_Letter_FRA_fra_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CSL624_2001_Site-Patient-Advocacy_Contact-List-for-ICF_AUT_Public | N/A |
| Subject information and informed consent form (for publication) | L2_CSL624_2001_Taxable-Payments-Letter_AUT_deu_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_CSL624_2001_Taxable-Payments-Letter_DEU_deu_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_CSL624_2001_Thank-You_Card_FRA_fra_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_CSL624-2001_Patient-Card_FRA_fra_Public | 1.0.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_BE-Dutch_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_BE-French_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_BE-GER_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_ENG_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_FRA_fra_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_IT-IT_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_NL_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ CSL Behring _CSL624_2001_Protocol synopsis_2025-523793-16-00_RO_RO_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_CSL Behring_CSL624_2001_Protocol synopsis_2025-523793-16-00_AT_GER_Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_CSL Behring_CSL624_2001_Protocol synopsis_2025-523793-16-00_CZE_CES _Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_CSL Behring_CSL624_2001_Protocol synopsis_2025-523793-16-00_ESP_SPA _Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_CSL_Behring_CSL624_2001_Protocol-Lay-Synopsis_2025-523793-16-00_Polish_PL_Public | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-12 | Germany | Acceptable 2026-04-20
|
2026-04-20 |