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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04576988




Registration number
NCT04576988
Ethics application status
Date submitted
28/09/2020
Date registered
6/10/2020

Titles & IDs
Public title
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Secondary ID [1] 0 0
7962-003
Secondary ID [2] 0 0
7962-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sotatercept
Treatment: Drugs - Placebo
Treatment: Drugs - Background PAH Therapy

Experimental: Sotatercept plus background PAH therapy - Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy

Placebo comparator: Placebo plus background PAH therapy - Placebo administered (SC) every 21 days plus background PAH therapy


Treatment: Other: Sotatercept
Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.

Treatment: Drugs: Placebo
Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.

Treatment: Drugs: Background PAH Therapy
Background PAH therapy may consist of the following drug classes: an endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or receptor agonist.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in 6-Minute Walk Distance (6MWD) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 24 weeks
Primary outcome [3] 0 0
Number of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [3] 0 0
Up to approximately 24 weeks
Secondary outcome [1] 0 0
Change From Baseline in the Percentage of Participants Achieving Multicomponent Improvement at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change From Baseline in NT-proBNP Levels at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change From Baseline in the Percentage of Participants Who Improve in WHO FC at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Time to Death or the First Occurrence of Clinical Worsening Event
Timepoint [5] 0 0
Up to approximately 18 months
Secondary outcome [6] 0 0
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator at Week 24
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Change From Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT®) at Week 24
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Change From Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT® at Week 24
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Change From Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT® at Week 24
Timepoint [9] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
Key

* Age = 18 years
* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (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 WHO Functional Class (FC) II or III
* Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of = 5 Wood units (WU) and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure of = 15 mmHg.
* On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice

* Background PAH therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with ERA, PDE5 inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists. Background PAH therapy should be stable at least 90 days prior to screening and remain stable throughout the study
* Stable diuretic therapy is defined as no addition of a new diuretic and no switching of a pre-existent oral diuretic to parenteral administration; however, dose adjustments (up or down) in pre-existent oral diuretics are acceptable
* 6-Minute Walk Distance (6MWD) = 150 and = 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
* Females of childbearing potential must:

* Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; she must agree to ongoing urine or serum pregnancy testing during the study and until 8 weeks after the last dose of the study drug
* If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, 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:
* 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
* Ability to adhere to study visit schedule and understand and comply with all protocol requirements
* Ability to understand and provide written informed consent

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of pulmonary hypertension 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. Exclusions in PAH Group I should also include schistosomiasis associate PAH and pulmonary veno occlusive disease
* Hemoglobin (Hgb) at screening above gender-specific upper limit of normal (ULN), per local laboratory test
* Baseline platelet count < 50,000/mm^3 (< 50.0 x 109/L) at screening
* Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during screening visit after a period of rest
* Baseline systolic blood pressure < 90 mmHg at screening
* Pregnant or breastfeeding women
* Any of the following clinical laboratory values at the screening visit:

* Estimated glomerular filtration rate (eGFR) < 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease [MDRD] equation)
* Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome)
* Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
* Prior exposure to sotatercept (ACE-011) or luspatercept (ACE 536) and/or excipients or known allergic reaction to either one
* History of full pneumonectomy
* Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing more than mild interstitial lung disease (ILD) at the screening visit or 1 year prior to it
* 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)
* History of more than mild obstructive sleep apnea that is untreated
* Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
* History of restrictive, constrictive or congestive cardiomyopathy
* History of atrial septostomy within 180 days prior to the screening visit
* Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the screening period
* Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
* Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit
* Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
* 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, vasopressin) within 30 days prior to the screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2022
Sample size
Target
Accrual to date
Final
324
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital ( Site 1106) - Camperdown
Recruitment hospital [2] 0 0
Saint Vincents Hospital Sydney ( Site 1102) - Darlinghurst
Recruitment hospital [3] 0 0
John Hunter Hospital ( Site 1101) - New Lambton
Recruitment hospital [4] 0 0
Westmead Hospital ( Site 1105) - Westmead
Recruitment hospital [5] 0 0
Prince Charles Hospital ( Site 1104) - Chermside
Recruitment hospital [6] 0 0
The Alfred Hospital ( Site 1110) - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
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Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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Texas
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Santa Fe
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Vlaams-Brabant
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
State/province [36] 0 0
Olomoucky Kraj
Country [37] 0 0
Czechia
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Praha 4
Country [38] 0 0
Czechia
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Praha, Hlavni Mesto
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France
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Alpes-Maritimes
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France
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Bas-Rhin
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France
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Finistere
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Gironde
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Haute-Garonne
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Herault
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Isere
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Loire-Atlantique
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France
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Loire
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France
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Maine-et-Loire
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Val-de-Marne
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Israel
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Haifa
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Israel
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Kefar Saba
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Israel
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Petah Tikva
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Israel
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Tel Hashomer
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Italy
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Roma
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Coahuila
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Mexico
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Nuevo Leon
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Mexico
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Huixquilucan
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Netherlands
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Limburg
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Netherlands
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Noord-Holland
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New Zealand
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Canterbury
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New Zealand
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Waikato
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New Zealand
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Auckland
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Poland
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Malopolskie
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Poland
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Mazowieckie
Country [77] 0 0
Poland
State/province [77] 0 0
Podlaskie
Country [78] 0 0
Serbia
State/province [78] 0 0
Beograd
Country [79] 0 0
Serbia
State/province [79] 0 0
Nisavski Okrug
Country [80] 0 0
Spain
State/province [80] 0 0
Cantabria
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Spain
State/province [81] 0 0
Madrid
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Spain
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Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Salamanca
Country [84] 0 0
Sweden
State/province [84] 0 0
Uppsala Lan
Country [85] 0 0
Sweden
State/province [85] 0 0
Vastra Gotalands Lan
Country [86] 0 0
Switzerland
State/province [86] 0 0
Geneve
Country [87] 0 0
Switzerland
State/province [87] 0 0
Zurich
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Glasgow City
Country [89] 0 0
United Kingdom
State/province [89] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gom... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04576988