Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
807
Countries
13
Sites
55
Pulmonary Arterial Hypertension (PAH)
To evaluate the long-term safety and tolerability of sotatercept.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2025-12-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2025-521970-33-00
- WHO UTN
- U1111-1321-4943
- ClinicalTrials.gov
- NCT04796337
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Therapy
To evaluate the long-term safety and tolerability of sotatercept.
Secondary objectives 1
- To evaluate the long-term efficacy of sotatercept.
Conditions and MedDRA coding
Pulmonary Arterial Hypertension (PAH)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064911 | Pulmonary arterial hypertension | 100000004855 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509138-21-00 | An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH | Acceleron Pharma Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Has completed the MK-7962-004 study requirements.
- Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements.
Exclusion criteria 2
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
- Is currently enrolled in another investigational product study other than a sotatercept study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 8
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
- Number of Participants With Detectable Anti-drug Antibodies (ADAs)
- Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit
- Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin
- Change From Baseline in Body Weight
- Change From Baseline in Blood Pressure
- Change From Baseline in Electrocardiogram (ECG)
Secondary endpoints 5
- Change From Baseline in 6-Minute Walk Distance (6MWD)
- Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
- Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC)
- Change From Baseline in Pulmonary Vascular Resistance (PVR)
- Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 37 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
- Modified vs. Marketing Authorisation
- No
PRD9659365 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 37 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
PRD9659366 · Product
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 37 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
SUB189200 · Substance
- Active substance
- Sotatercept
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.7 mg/kg milligram(s)/kilogram
- Max total dose
- 37 mg/kg milligram(s)/kilogram
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2369
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Howard Julien
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Howard Julien
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Pra International ORG-100032850
|
Blue Bell, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Pra International ORG-100032850
|
Blue Bell, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| QPS LLC ORG-100012847
|
Newark, United States | Laboratory analysis |
Locations
13 EU/EEA countries · 55 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 10 | 2 |
| Croatia | Ongoing, recruitment ended | 1 | 1 |
| Czechia | Ongoing, recruitment ended | 24 | 2 |
| Denmark | Ongoing, recruitment ended | 8 | 2 |
| France | Ongoing, recruiting | 71 | 13 |
| Germany | Ongoing, recruiting | 148 | 11 |
| Greece | Ongoing, recruiting | 12 | 3 |
| Italy | Ongoing, recruitment ended | 18 | 4 |
| Netherlands | Ongoing, recruitment ended | 12 | 3 |
| Poland | Ongoing, recruiting | 27 | 2 |
| Portugal | Ongoing, recruitment ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 47 | 9 |
| Sweden | Ongoing, recruitment ended | 1 | 1 |
| Rest of world
Israel, Canada, Korea, Republic of, Taiwan, Argentina, United States, Mexico, Serbia, New Zealand, Australia, Colombia, Switzerland, United Kingdom, Brazil
|
— | 418 | — |
Investigational sites
Hopital Erasme
Pneumology, Lennikse Baan 808, 1070, Anderlecht
UZ Leuven
Pneumology, Herestraat 49, 3000, Leuven
Vseobecna Fakultni Nemocnice V Praze
Centrum pro plicní hypertenzi VFN II.interní klinika VFN a 1.LF UK, U Nemocnice 499/2, Nove Mesto, Prague
Institute For Clinical And Experimental Medicine
Centrum pro léčbu plicní hypertense, klinika kardiologie, Videnska 1958/9, Krc, Prague
Rigshospitalet
Cardiology Trial Unit 9631, Blegdamsvej 9, 2100, Copenhagen Oe
Region Midtjylland
Dept. of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire De Nice
Cardiology department, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Saint Etienne
vascular medicine and therapeutics department, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Bicetre Hospital
Pneumology department, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Pneumology department, Boulevard Tanguy Prigent, 29200, Brest
Les Hopitaux Universitaires De Strasbourg
Pneumology department, 1 Place De L Hopital, 67000, Strasbourg
Centre Hospitalier Universitaire De Nantes
Pneumology department, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Poitiers
Pneumology department, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Lille
Cardiology department, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Cardiology and cardiovascular diseases department, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology department, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire D'Angers
Respiratory and Sleep medicine department, 4 Rue Larrey, 49100, Angers
Hospices Civils De Lyon
Pneumology department, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Toulouse
Pneumology department, 24 Chemin De Pouvourville, 31400, Toulouse
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Innere Medizin II-Kardiologie, Pneumologie, Internistische Intensivmedizin, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Krankenhaus Neuwittelsbach
Zentrum für Lungenhochdruck, Renatastrasse 71a, Neuhausen-Nymphenburg, Munich
Universitaetsklinikum Halle (Saale) AöR
Department für Innere Medizin Innere Medizin I (Gastroenterologie, Pneumologie), Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
DRK Kliniken Berlin
Klinik für Innere Medizin - Kardiologie, Spandauer Damm 130, 14050, Berlin
Justus-Liebig-Universitaet Giessen
Medizinische Klinik und Poliklinik II, Klinikstrasse 33, 35392, Giessen
Thoraxklinik Heidelberg gGmbH
Universitaetsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
Universitaetsklinikum Koeln AöR
Innere Medizin III, Kerpener Strasse 62, Lindenthal, Cologne
Universitaet Leipzig
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Technische Universitaet Dresden
Innere Medizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medizinische Hochschule Hannover
Klinik für Pneumologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum des Saarlandes AöR
Klinik für Innere Medizin V - Pneumologie, Allergologie, Beatmungs- und Umweltmedizin, Kirrberger Strasse 100, 66421, Homburg
Onassis Cardiac Surgery Center
Cardiology Department, Leoforos Andrea Siggrou 356, 176 74, Kallithea
University General Hospital Of Thessaloniki Ahepa
1st Cardiology Department, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Department of Critical Care, Rimini 1, 124 61, Chaidari
Azienda Ospedaliera Dei Colli
Cardiologia SUN Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare, Via Leonardo Bianchi, 80131, Naples
Multimedica S.p.A.
Ambulatorio Pneumologia, Via San Vittore 12, 20123, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
U.O.C. Malattie Cardiovascolari, Viale Del Policlinico 155, 00161, Rome
Fondazione IRCCS San Gerardo Dei Tintori
S.C. Pneumologia Centro di Ricerca di fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pulmonary Diseases, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Radboud universitair medisch centrum Stichting
Rheumatology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC Stichting
Longgeneeskunde, De Boelelaan 1117, 1081 HV, Amsterdam
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Ul. Pradnicka 80, 31-202, Cracow
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Szpital im. Fryderyka Chopina Oddział Kardiologiczny, Ul. Borowa 14/18, 05-400, Otwock
Unidade Local De Saude De Almada-Seixal E.P.E.
Cardiology, Avenida Torrado Da Silva, 2805-267, Almada
Unidade Local De Saude De Santa Maria E.P.E.
Cardiology, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Hospital Universitario Marques De Valdecilla
Neumology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Ramon Y Cajal
Cardiology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinic De Barcelona
Neumology, Calle Villarroel 170, 08036, Barcelona
University Hospital Son Espases
Neumology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario De Toledo
Cardiology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario Puerta De Hierro De Majadahonda
Cardiology, Calle De Manuel De Falla 1, 28222, Majadahonda
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Neumology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Cardiology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario La Paz
Neumology, Paseo De La Castellana 261, 28046, Madrid
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 |
|---|---|---|---|---|---|
| Belgium | 2026-02-25 | 2026-03-03 | 2026-05-05 | ||
| Croatia | 2026-03-27 | 2026-04-17 | 2026-04-17 | ||
| Czechia | 2026-01-27 | 2026-02-03 | 2026-04-02 | ||
| Denmark | 2025-12-19 | 2026-01-23 | 2026-02-11 | ||
| France | 2026-01-12 | 2026-01-27 | |||
| Germany | 2026-04-09 | 2026-04-15 | |||
| Greece | 2026-03-12 | 2026-03-13 | |||
| Italy | 2026-02-23 | 2026-03-04 | 2026-05-04 | ||
| Netherlands | 2025-12-22 | 2026-02-10 | 2026-03-25 | ||
| Poland | 2026-04-30 | 2026-05-12 | |||
| Portugal | 2026-02-25 | 2026-03-12 | 2026-05-28 | ||
| Spain | 2025-12-19 | 2025-12-29 | 2026-04-16 | ||
| Sweden | 2026-01-14 | 2026-02-03 | 2026-02-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 94 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521970-33_GRC_EL_IN_for pub | 00R |
| Protocol (for publication) | D1_Protocol_2025-521970-33_IN_for pub | 00R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_IN-RFI006_for pub | 20OCT2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_IN_for pub | 30JUL2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_IN-RFI014_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN-RFI011_for pub | 28OCT2025R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_IN_for pub | 04AUG2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HRV_EN_IN_for pub | 0.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_IN_for pub | 21JUL2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_IN-RFI020_for pub | v3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_IN_for pub | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Letter_BEL_FR_IN-RFI006_for pub | v00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Letter_BEL_NL_IN-RFI006_for pub | v00.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_CZE_CS_IN-RFI010_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DNK_DA_IN-RFI014_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_GRC_EL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_HRV_HR_IN-RFI008_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_POL_PL_IN-RFI022_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_PRT_PT_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main adult consent_ESP_ES_IN-RFI011_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_IN-RFI006_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_IN-RFI006_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_IN-RFI019_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_IN-RFI010_for pub | 1R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM06_for pub | 0.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_SM02_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_IN_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_GRC_EL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HRV_HR_IN-RFI008_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_IN-RFI002_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_SM13_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_IN-RFI013_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_PT_IN-RFI004_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_IN-RFI007_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_NSM01_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_IN_for pub | Czech v3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_BEL_EN_SM04_for pub | v0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_BEL_FR_SM04_for pub | v0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_BEL_NL_SM04_for pub | v0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_DEU_DE_SM06_for pub | 0.1R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_DNK_DA_IN-RFI014_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_FRA_FR_IN_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_GRC_EL_SM07_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_HRV_HR_IN-RFI008_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_ITA_IT_SM08_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_NLD_NL_IN-RFI020_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_POL_PL_SM10_for pub | 01R |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_PRT_PT_SM11_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main survival follow-up_SWE_SV_IN-RFI007_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_additional treatment_DEU_DE_SM06_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_NSM01_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_CZE_CS_IN_for pub | Czech v1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_DEU_DE_IN_for pub | 0.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_IN_for pub | 0.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_POL_PL_SM10_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_PRT_PT_IN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_SWE_SV_IN-RFI007_for pub | v0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Home healthcare_FRA_FR_SM03_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_infant follow-up_POL_PL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_HRV_HR_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_POL_PL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_PRT_PT_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner assent_HRV_HR_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner parent_HRV_HR_IN-RFI008_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_EN_IN-RFI006_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_FR_IN-RFI006_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_BEL_NL_IN-RFI006_for pub | v0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HRV_HR_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_IN-RFI014_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_survival follow-up_CZE_CS_IN-RFI010_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_withdrawal_PRT_PT_IN_for pub | 00 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_BEL_DE_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_BEL_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_BEL_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_CZE_CS_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_DEU_DE_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_ESP_ES_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_FRA_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_GRC_EL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_HRV_HR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_ITA_IT_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_NLD_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_POL_PL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_PRT_PT_IN_for pub | 1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-521970-33_SWE_SV_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2025-521970-33_CZE_CS_IN_for pub | 1.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Denmark | Acceptable 2025-12-01
|
2025-12-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-09 | Acceptable 2025-12-01
|
2026-01-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-22 | Acceptable | 2026-03-02 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-02 | Denmark | Acceptable | 2026-02-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-20 | Acceptable | 2026-03-16 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-24 | Acceptable | 2026-04-09 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-24 | Acceptable | 2026-04-29 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-25 | Acceptable | 2026-05-04 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-03-25 | Acceptable | 2026-05-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-25 | Acceptable | 2026-04-23 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-26 | Acceptable | 2026-04-29 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-03-26 | Acceptable | 2026-04-08 |