Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified April 2026 by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Information Provided by (Responsible Party)
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Clinicaltrials.gov Identifier
NCT04811092
Other Study ID Numbers:
7962-005
First Submitted
March 15, 2021
First Posted
March 22, 2021
Results First Posted
March 23, 2026
Last Update Posted
June 7, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- or high risk PAH participants.

Participants enrolled in the study will have a diagnosis within 12 months of study screening of symptomatic PAH (World Health Organization \[WHO\] Group 1, classified as functional class \[FC\] II or III) and presentation of idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxin- induced PAH, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects.

As of Amendment 11, this study will be closed so that all eligible participants can receive sotatercept either on the MK-7962-004 extension study (SOTERIA, NCT04796337) or by commercial access, if available. All eligible participants will complete the end of treatment visit before enrollment in the extension study or initiation of commercial product. Participants not enrolling into the extension study or initiating commercial product will complete the end of study visit.

Condition or DiseaseIntervention/Treatment
Pulmonary Arterial Hypertension
Drug: SotaterceptOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment321 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients
Study Start DateMarch 17, 2022
Actual Primary Completion DateApril 2, 2025
Actual Study Completion DateApril 2, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Sotatercept plus background PAH therapy
Participants received sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, subcutaneously (SC) every 21 days plus background PAH therapy.
Drug: Sotatercept
SC injection
Placebo plus background therapy
Participants received placebo SC every 21 days plus background PAH therapy.
Other: Placebo
Placebo-matched SC injection

Outcome Measures

Primary Outcome Measures
  1. Median Time to Clinical Worsening
    Time to clinical worsening (TTCW) is defined as time from randomization to the first confirmed morbidity event or death. Clinical worsening events are defined as all-cause death, non-planned PAH-related hospitalization of ≥ 24 hours in duration, atrial septostomy, lung transplant, and/or deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral. All events were adjudicated by a blinded, independent committee of clinical experts. The median TTCW is presented.
Secondary Outcome Measures
  1. Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal Prohormone B-type Natriuretic Peptide (NT-ProBNP) WHO FC
    The multicomponent improvement outcome measure is determined by the percentage of participants achieving all of the following at Week 24 relative to baseline: * Improvement in 6MWD (increase ≥30 m) * Improvement or maintenance/achievement of NT-proBNP (decrease in NT-proBNP ≥30%) or maintenance/achievement of NT-proBNP level \<300 ng/L * Improvement in WHO FC or maintenance of WHO FC II (indicated by maintaining the same WHO FC or a lower WHO FC by Week 24 relative to baseline) The percentage of participants achieving the multicomponent improvement endpoint is presented.
  2. Percentage of Participants Who Maintained or Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score
    REVEAL Lite 2.0 risk scoring is used to guide PAH treatment decisions. Total score uses 6 variables with each assessed based on contribution to mortality risk. Variables and sub-score ranges: estimated glomerular filtration rate \[eGFR\] (0, +1), WHO FC (-1, 0, +1, +2), SBP (0, +1), heart rate (0, +1), 6MWD (-2, -1, 0, +1), and NT-proBNP (-2, 0, +2). Sub-scores are added to a base score of +6 and a total score of 1 to 14 is obtained (≤5=low risk; 6,7=intermediate risk; ≥8=high risk). A higher score = higher risk. Per SAP, participants who did not have a REVEAL risk score at Week 24 were considered as non-responders and multiple imputation was not conducted for this endpoint. Comparisons between this analysis reporting non-imputed data should not be made to other REVEAL analyses which included imputation of missing Week 24 data. The percentage of participants who maintained or achieved a low REVEAL Lite 2.0 score at Week 24 is reported.
  3. Percentage of Participants Who Maintained or Achieved a Low Simplified French Risk Score
    The simplified French Risk Score uses WHO FC, 6MWD, and NT-proBNP to determine the total risk score. A low risk score can be defined as attaining or maintaining all three low-risk criteria: WHO FC I or II, 6MWD \> 440m, and NT-proBNP \< 300 ng/L. The percentage of participants who maintained or achieved a low risk score at Week 24 versus baseline using the simplified French Risk score calculator is presented.
  4. Median Change From Baseline in NT-proBNP Levels at Week 24
    NT-proBNP is a circulating biomarker that reflects myocardial stretch and is an established biomarker used to determine the ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The median change from baseline in NT-proBNP at Week 24 is presented.
  5. Percentage of Participants Who Improved in WHO FC or Maintained WHO FC II at 24 Weeks From Baseline
    The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC is classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The percentage of participants who improved in WHO FC or maintained WHO FC II at 24 Weeks from Baseline is presented.
  6. Median Change From Baseline in Six-Minute Walk Distance (6MWD)
    The 6-minute walk distance (6MWD) was measured using the 6-Minute Walk Test (6MWT). The 6MWT measures the distance covered in 6 minutes and is intended to measure changes in functional exercise capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicated improvement in functional exercise capacity. Median change from baseline in 6MWD at Week 24 is reported.
  7. Overall Survival (OS)
    Overall survival is defined as the time from randomization to date of death due to any cause. OS is presented.
  8. Mean Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®
    The PAH SYMPACT is a 23-item questionnaire to measure pulmonary arterial hypertension (PAH)-related symptoms and impact of PAH on daily life. The physical impact domain consists of walking slowly on a flat surface, walking quickly on a flat surface, walking uphill, carrying things, doing light indoor household chores, washing, or dressing oneself, and needing help from others. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no physical impact to 4=severe physical impact). A higher score indicated more severe physical impact. Mean change from baseline in responses in physical symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported.
  9. Mean Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
    The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The cardiopulmonary symptoms consist of shortness of breath, fatigue, lack of energy, swelling in the ankles or legs, swelling in the stomach area, and cough. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (no symptom at all) to 4 (very severe symptoms). The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items (range: 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms). A higher score indicated more severe symptoms experienced. Mean change from baseline in cardiopulmonary symptoms of the PAH-SYMPACT questionnaire at Week 24 is reported.
  10. Mean Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®
    The PAH SYMPACT is a 23-item questionnaire to measure PAH-related symptoms and impact of PAH on daily life. The Cognitive/Emotional Impact domain consists of thinking clearly, feeling sad, feeling worried, and feeling frustrated. Participants were asked to recall and report on each item experienced in past 7 days. Score for each item ranges from 0 (not difficult at all) to 4 (extremely difficult). A domain score was calculated by summing the individual responses for each item and dividing by the number of impact items (range: 0=no cognitive/emotional impact to 4=severe cognitive/emotional impact). A higher score indicated more severe cognitive/emotional impact. Mean change from baseline in responses in the Cognitive/Emotional Impacts Domain Score of the PAH-SYMPACT questionnaire at Week 24 is reported.
  11. Percentage of Participants Who Experience an Adverse Event (AE)
    An AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced an AE are presented.
  12. Percentage of Participants Who Discontinued Study Treatment Due to AEs
    An AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE are presented.
  13. Number of Participants Who Had Anti-drug Antibodies (ADAs) to Sotatercept
    Blood samples collected at designated timepoints were used to determine the ADA response to sotatercept. The number of participants who had ADAs to sotatercept over time is presented.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion criteria include but are not limited to:
Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum pulmonary vascular resistance (PVR) of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
PAH associated with connective tissue disease
PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
Symptomatic PAH classified as World Health Organization (WHO) Functional Class (FC) II or III
Either Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 6 or Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) 2.0 risk score ≥2 (intermediate to-low-risk or above)
Diagnosis of PAH within 12 months of screening and on stable doses of a double or triple combination of background PAH therapies and diuretics (if any) for at least 90 days prior to screening
Six-minute walk distance ≥ 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)
Females of childbearing potential must meet the following criteria:
Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
If sexually active with a male partner, have used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product AND agreed to use the same highly effective contraception in combination with a barrier method during the study (including dose interruptions) and for 16 weeks (112 days) after discontinuation of study treatment
Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment
Male participants must meet the following criteria:
Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
Exclusion Criteria
Exclusion Criteria include but are not limited to:
Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis
Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) \> 180 mmHg or sitting diastolic BP \> 110 mmHg during the Screening Visit after a period of rest
Baseline systolic BP \< 90 mmHg at screening
Pregnant or breastfeeding women
Any of the following clinical laboratory values at the Screening Visit:
Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2 (as defined by The Modification of Diet in Renal Disease \[MDRD\] equation)
Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels \> 3 × ULN
Platelet count \< 50,000/mm\^3 (\< 50.0 × 10\^9 /L)
Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented informed consent
Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
History of pneumonectomy
Pulmonary function test values of forced vital capacity \< 60% predicted within 1 year prior to the Screening Visit
Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the Screening Visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
Untreated more than mild obstructive sleep apnea
History of known pericardial constriction
History of restrictive or congestive cardiomyopathy
History of atrial septostomy within 180 days prior to the Screening Visit
Electrocardiogram with Fridericia's corrected QT interval \> 500 ms during the Screening Period
Personal or family history of long QT syndrome or sudden cardiac death
Left ventricular ejection fraction \< 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
Cerebrovascular accident within 3 months prior to the Screening Visit
Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
Has an active malignancy with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or prostate cancer that is not currently or expected, during the study, to be treated with radiation therapy, chemotherapy, and/or surgical intervention, or hormonal treatment

Contacts and Locations

Sponsors and CollaboratorsAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Locations
Arizona Pulmonary Specialists ( Site 1010) | Scottsdale Arizona, United States, 85258University of Arizona ( Site 1006) | Tucson Arizona, United States, 85724University of California San Diego ( Site 1002) | La Jolla California, United States, 92037UCLA Medical Center ( Site 1068) | Los Angeles California, United States, 90095University of California Irvine ( Site 1086) | Orange California, United States, 92868Santa Barbara Pulmonary Associates ( Site 1060) | Santa Barbara California, United States, 93105-5316University of California Davis Medical Center ( Site 1064) | Sherman Oaks California, United States, 95817University of Colorado Hospital ( Site 1013) | Aurora Colorado, United States, 80045AdventHealth Medical Group Advanced Lung Disease ( Site 1058) | Orlando Florida, United States, 32804University of Iowa Hospital and Clinics ( Site 1050) | Iowa City Iowa, United States, 52242Johns Hopkins Hospital ( Site 1036) | Baltimore Maryland, United States, 21287-0005Tufts Medical Center - PPDS ( Site 1014) | Boston Massachusetts, United States, 02111-1526Boston Medical Center ( Site 1012) | Boston Massachusetts, United States, 02118University of Michigan ( Site 1011) | Ann Arbor Michigan, United States, 48109University of Kansas Medical Center ( Site 1020) | Kansas City Missouri, United States, 66160Washington University School of Medicine ( Site 1022) | St Louis Missouri, United States, 63110University of New Mexico, Health Sciences Center ( Site 1048) | Albuquerque New Mexico, United States, 87131NYU Langone Health ( Site 1052) | New York New York, United States, 10016-9196University of North Carolina at Chapel Hill ( Site 1042) | Chapel Hill North Carolina, United States, 27514The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati Ohio, United States, 45219University of Cincinnati ( Site 1035) | Cincinnati Ohio, United States, 45219The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065) | Cleveland Ohio, United States, 44195Nazih Zuhdi Transplantation Institute ( Site 1084) | Oklahoma City Oklahoma, United States, 73112-4421Oregon Health & Science University ( Site 1054) | Portland Oregon, United States, 97239Medical University of South Carolina ( Site 1003) | Charleston South Carolina, United States, 29425-8900Vanderbilt University Medical Center ( Site 1027) | Nashville Tennessee, United States, 37232University of Texas Southwestern Medical Center ( Site 1038) | Dallas Texas, United States, 78701University of Utah ( Site 1049) | Salt Lake City Utah, United States, 84132-0001Cardiologia Palermo ( Site 1911) | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1425BNGCentro Medico Dra De Salvo ( Site 1904) | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1426ABPHospital Universitario Austral ( Site 1901) | Pilar Buenos Aires, Argentina, B1629ODTInstituto de Investigaciones Clinicas Quilmes ( Site 1903) | Quilmes Buenos Aires, Argentina, 1878Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910) | Villa Vatteone Buenos Aires, Argentina, B1853AIKInstituto Médico DAMIC ( Site 1909) | Córdoba Córdoba Province, Argentina, 5003DCEInstituto Medico Rio Cuarto ( Site 1907) | Río Cuarto Córdoba Province, Argentina, X5800AEVHospital Provincial del Centenario ( Site 1912) | Rosario Santa Fe Province, Argentina, 2002Instituto Cardiovascular de Rosario ( Site 1906) | Rosario Santa Fe Province, Argentina, S2000DSRSanatorio Parque ( Site 1905) | Rosario Santa Fe Province, Argentina, S2000DSVSanatorio Allende ( Site 1908) | Córdoba , Argentina, X5021FPQHospital Provincial Dr. Jose M. Cullen ( Site 1902) | Santa Fe , Argentina, S3000EOZRoyal Prince Alfred Hospital ( Site 1106) | Camperdown New South Wales, Australia, 2050John Hunter Hospital ( Site 1101) | Newcastle New South Wales, Australia, 2308Prince Charles Hospital ( Site 1104) | Chermside Queensland, Australia, 4032Princess Alexandra Hospital ( Site 1108) | Woolloongabba Queensland, Australia, 4102Royal Adelaide Hospital ( Site 1109) | Adelaide South Australia, Australia, 5000Royal Hobart Hospital ( Site 1107) | Hobart Tasmania, Australia, 7000Fiona Stanley Hospital ( Site 1103) | Murdoch Western Australia, Australia, 6150Medizinische Universitat Wien ( Site 2001) | Vienna State of Vienna, Austria, 1090Medizinische Universität Graz ( Site 2003) | Graz Styria, Austria, 8036Medizinische Universitat Innsbruck ( Site 2004) | Innsbruck Tyrol, Austria, 6020Ordensklinikum Linz GmbH Elisabethinen ( Site 2002) | Linz Upper Austria, Austria, 4020Hopital Erasme ( Site 1402) | Anderlecht Bruxelles-Capitale, Region de, Belgium, 1070UZ Gasthuisberg ( Site 1401) | Leuven Vlaams-Brabant, Belgium, 3000Hospital Madre Teresa ( Site 1804) | Belo Horizonte Minas Gerais, Brazil, 30430-142Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805) | Porto Alegre Rio Grande do Sul, Brazil, 90020-090Hospital Sao Paulo ( Site 1806) | São Paulo São Paulo, Brazil, 04038-031Instituto do Coracao - HCFMUSP ( Site 1803) | São Paulo , Brazil, 05403-000University of Alberta Hospital ( Site 2101) | Edmonton Alberta, Canada, T6G 2B7St Boniface General Hospital ( Site 2106) | Winnepeg Manitoba, Canada, R2H 2A6McMaster University - HSC ( Site 2105) | Hamilton Ontario, Canada, L8N 4A6Sir Mortimer B Davis Jewish General Hospital ( Site 2103) | Montreal Quebec, Canada, H3T 1E2Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402) | Medellín Antioquia, Colombia, 50034Fundacion Neumologica Colombiana ( Site 3403) | Bogota Cundinamarca, Colombia, 110131Fundacion Valle Del Lili ( Site 3401) | Cali Valle del Cauca Department, Colombia, 760032Centro Medico Imbanaco de Cali S.A ( Site 3404) | Cali Valle del Cauca Department, Colombia, 760042University Hospital Centre Split city ( Site 3901) | Split Split-Dalmatia County, Croatia, 21000Klinicki Bolnicki Centar Zagreb ( Site 3902) | Zagreb Zagreb County, Croatia, 10000Institut Klinicke a Experimentalni Mediciny ( Site 2202) | Prague Praha 4, Czechia, 140 21Vseobecna fakultni nemocnice v Praze ( Site 2201) | Prague , Czechia, 128 08Rigshospitalet ( Site 3802) | København Ø Capital Region, Denmark, 2100Aarhus Universitetshospital, Skejby ( Site 3801) | Aarhus Central Jutland, Denmark, 8200Hopital Louis Pasteur ( Site 1311) | Nice Alpes-Maritimes, France, 06001Hopital Louis Pradel ( Site 1317) | Lyon Auvergne, France, 69003Hopitaux Universitaires de Strasbourg ( Site 1307) | Strasbourg Bas-Rhin, France, 67000Hopital Cavale Blanche ( Site 1314) | Brest Brittany Region, France, 29200CHU Caen Normandie ( Site 1325) | Caen Calvados, France, 14033CHU de Besancon ( Site 1303) | Besançon Doubs, France, 25000Hopital Haut Leveque ( Site 1312) | Bordeaux Gironde, France, 33604CHU de Toulouse - Hopital Larrey ( Site 1315) | Toulouse Haute-Garonne, France, 31059C.H.U. de Tours - Hopital Bretonneau ( Site 1310) | Tours Indre-et-Loire, France, 37000Hopital Nord Laennec ( Site 1309) | Nantes Loire-Atlantique, France, 44000CHU Angers ( Site 1313) | Angers Maine-et-Loire, France, 49933C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) | Vandœuvre-lès-Nancy Meurthe-et-Moselle, France, 54500Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) | Saint-Priest-en-Jarez Pays de la Loire Region, France, 42270CHU - Hopital de Bicetre ( Site 1304) | Le Kremlin-Bicêtre Val-de-Marne, France, 94270CHU de Poitiers ( Site 1316) | Poitiers Vienne, France, 86000Universitaetsklinikum Heidelberg ( Site 1509) | Heidelberg Baden-Wurttemberg, Germany, 69120Krankenhaus Neuwittelsbach ( Site 1510) | Munich Bavaria, Germany, 80639Universitaetsklinik Regensburg ( Site 1503) | Regensburg Bavaria, Germany, 93053Medizinische Hochschule Hannover ( Site 1505) | Hanover Lower Saxony, Germany, 30625Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512) | Bad Oeynhausen North Rhine-Westphalia, Germany, 35392Uniklinik Köln ( Site 1511) | Cologne North Rhine-Westphalia, Germany, 50937Universitatsklinikum des Saarlandes ( Site 1513) | Homburg Saarland, Germany, 66421Universitaetsklinikum Carl Gustav Carus ( Site 1501) | Dresden Saxony, Germany, 01307Universitatsklinikum Leipzig ( Site 1508) | Leipzig Saxony, Germany, 04103Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502) | Halle Saxony-Anhalt, Germany, 06120DRK Kliniken Berlin Westend ( Site 1507) | Berlin , Germany, 14050Evangelismos General Hospital of Athens ( Site 3605) | Athens Attica, Greece, 106 76Onassis Cardiac Surgery Center ( Site 3602) | Athens Attica, Greece, 176 74Attikon University General Hospital of Athens ( Site 3604) | Haidari Attica, Greece, 124 62AHEPA University General Hospital of Thessaloniki ( Site 3601) | Thessaloniki , Greece, 546 36Assuta Ashdod Medical Center ( Site 1710) | Ashdod , Israel, 7747629Lady Davis Carmel Medical Center ( Site 1705) | Haifa , Israel, 3436212Hadassah Medical Center ( Site 1711) | Jerusalem , Israel, 9112001Sheba Medical Center ( Site 1701) | Tel Litwinsky , Israel, 52621Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405) | Trieste Friuli Venezia Giulia, Italy, 34149Ospedale S. Giuseppe Multimedica ( Site 2403) | Milan Lombardy, Italy, 20123Azienda Ospedaliera San Gerardo di Monza ( Site 2406) | Monza Monza E Brianza, Italy, 20900Azienda Ospedaliera R. N. V. Monaldi ( Site 2407) | Naples , Italy, 80131La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402) | Roma , Italy, 161Radboud University Nijmegen Medical Centre ( Site 2605) | Nijmegen Gelderland, Netherlands, 6500 HBMaastricht University Medical Center ( Site 2603) | Maastricht Limburg, Netherlands, 6229 HXVU Medisch Centrum ( Site 2601) | Amsterdam North Holland, Netherlands, 1081 HVErasmus MC ( Site 2604) | Rotterdam South Holland, Netherlands, 3015 GDWaikato District Health Board ( Site 2702) | Hamilton Waikato Region, New Zealand, 3204Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) | Krakow Lesser Poland Voivodeship, Poland, 31-202Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 2802) | Warsaw Masovian Voivodeship, Poland, 01-138Hospital Garcia de Orta ( Site 3501) | Almada Setúbal District, Portugal, 2801-951Centro Hospitalar E Universitário De Coimbra ( Site 3502) | Coimbra , Portugal, 3000-075Hospital Pulido Valente ( Site 3503) | Lisbon , Portugal, 1769-001Institute for pulmonary diseases of Vojvodina ( Site 2906) | Kamenitz Juznobacki Okrug, Serbia, 21204University Clinical Center Nis ( Site 2904) | Niš Nisavski Okrug, Serbia, 18000Clinical Center Kragujevac ( Site 2905) | Kragujevac Sumadijski Okrug, Serbia, 34000Clinical Center of Serbia ( Site 2901) | Belgrade , Serbia, 11000Gachon University Gil Medical Center ( Site 3103) | Namdong-Gu Incheon, South Korea, 21565Chonnam National University Hospital ( Site 3105) | Gwangju Kyonggi-do, South Korea, 61469Samsung Medical Center ( Site 3106) | Seuol Seoul, South Korea, 06351Seoul National University Hospital ( Site 3102) | Seoul , South Korea, 03080Severance Hospital Yonsei University Health System - PPDS ( Site 3101) | Seoul , South Korea, 03722The Catholic University of Korea St. Mary s Hospital ( Site 3104) | Seoul , South Korea, 06591Hospital Universitario de Son Espases ( Site 1611) | Palma de Mallorca Balearic Islands, Spain, 07120Hospital Universitario Marques de Valdecilla ( Site 1601) | Santander Cantabria, Spain, 39008Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604) | Majadahonda Madrid, Spain, 28222Hospital Universitari Vall de Hebron ( Site 1605) | Barcelona , Spain, 08035Hospital Universitario 12 de Octubre ( Site 1603) | Madrid , Spain, 28041Hospital Universitario La Paz ( Site 1610) | Madrid , Spain, 28046Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608) | Salamanca , Spain, 37007Hospital Virgen de la Salud ( Site 1607) | Toledo , Spain, 45004Skanes Universitetssjukhus Lund ( Site 3203) | Lund Skåne County, Sweden, 22185Hjart-lungmedicin och klinisk fysiologi ( Site 3204) | Uppsala Uppsala County, Sweden, 751 85Norrlands Universitetssjukhus ( Site 3205) | Umeå Västerbotten County, Sweden, 90185UniversitätsSpital Zürich ( Site 3301) | Zurich , Switzerland, 8091Kaohsiung Veterans General Hospital ( Site 3702) | Kaohsiung City , Taiwan, 81362China Medical University Hospital ( Site 3701) | Taichung , Taiwan, 40447National Cheng Kung University Hospital ( Site 3703) | Tainan , Taiwan, 704Papworth Hospital NHS Foundation Trust ( Site 1208) | Cambrigge Cambridgeshire, United Kingdom, CB23 0AYSheffield Teaching Hospital NHS Foundation Trust ( Site 1207) | Sheffield Derbyshire, United Kingdom, S10 2JFGolden Jubilee National Hospital ( Site 1204) | Glasgow Glasgow City, United Kingdom, G81 4DYRoyal Free London NHS Foundation Trust ( Site 1202) | London London, City of, United Kingdom, NW3 2QGRoyal Brompton Hospital ( Site 1206) | London London, City of, United Kingdom, SW3 6HPImperial College Healthcare NHS Trust ( Site 1203) | London London, City of, United Kingdom, W12 OHSFreeman Hospital ( Site 1205) | Newcastle upon Tyne , United Kingdom, NE7 7DN
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full Text)
Documents provided by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: Study Protocol and Statistical Analysis Plan  December 16, 2024