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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04811092




Registration number
NCT04811092
Ethics application status
Date submitted
16/03/2021
Date registered
23/03/2021
Date last updated
13/05/2025

Titles & IDs
Public title
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Scientific title
A 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
Secondary ID [1] 0 0
A011-13
Secondary ID [2] 0 0
7962-005
Universal Trial Number (UTN)
Trial acronym
HYPERION
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: Drugs - Sotatercept
Other interventions - Placebo

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

Experimental: Sotatercept plus background PAH therapy - Administered 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


Treatment: Drugs: Sotatercept
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1

Other interventions: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Clinical Worsening
Assessment method [1] 0 0
Time to clinical worsening 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 deterioration in performance in 6-minute walk test from baseline combined with one of the following conditions: worsening of WHO functional class 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 will be adjudicated by a blinded, independent committee of clinical experts.
Timepoint [1] 0 0
Up to ~36 months
Secondary outcome [1] 0 0
Percentage of Participants Achieving the Multicomponent Improvement Endpoint of 6-Minute Walk Distance (6MWD), N-terminal prohormone Btype natriuretic peptide (NT-ProBNP) and World Health Organization (WHO) Functional Class (FC)
Assessment method [1] 0 0
Multicomponent improvement endpoint measured by the percentage of participants achieving all of the following at Week 24 relative to baseline: * Improvement in 6MWD * Improvement or maintenance/achievement of NT-proBNP * Improvement in WHO FC or maintenance of WHO FC II
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of Participants who Achieved a Low Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 Risk Score
Assessment method [2] 0 0
The REVEAL Lite 2 uses renal insufficiency (by estimated glomerular filtration rate (eGFR)), WHO FC, systolic blood pressure (SBP) and heart rate, 6MWD, and NT-proBNP to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of =5, intermediate risk as a score of 6 or 7, and high risk as a score of =8 for the survival rates.
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Participants who Maintain or Achieve a Low Simplified French Risk Score
Assessment method [3] 0 0
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 maintain or achieve a low risk score at Week 24 versus baseline using the simplified French Risk score calculator will be reported.
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change from Baseline in NT-proBNP Levels
Assessment method [4] 0 0
Blood samples will be collected at baseline and at Week 24 to measure NT-proBNP blood concentration.
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Percentage of Participants who Improve in WHO FC or Maintain WHO FC II at 24 Weeks from Baseline
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Change from Baseline in 6MWD
Assessment method [6] 0 0
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. Change from baseline in 6MWD at Week 24 will be reported.
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Overall Survival (OS)
Assessment method [7] 0 0
Overall survival is defined as the time from randomization to date of death due to any cause.
Timepoint [7] 0 0
Up to ~36 Months
Secondary outcome [8] 0 0
Change from Baseline in the Physical Impacts Domain Score of Pulmonary Arterial Hypertension Symptoms and Impact (PAH-SYMPACT)®
Assessment method [8] 0 0
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Change from Baseline in the Cardiopulmonary Symptoms Domain Score of PAH-SYMPACT®
Assessment method [9] 0 0
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported.
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change from Baseline in the Cognitive/Emotional Impacts Domain Score of PAH-SYMPACT®
Assessment method [10] 0 0
PAH SYMPACT is a self-rating questionnaire to assess symptoms and their physical and cognitive/emotional impact. The PAH-SYMPACT® questionnaire consists of consists of 16 symptom and 25 impact items. A higher score indicates worse symptoms. Change from baseline in responses in PAH-SYMPACT questionnaire at Week 24 will be reported
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Number of Participants who Experience an Adverse Event (AE)
Assessment method [11] 0 0
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 number of participants who experienced an AE are presented.
Timepoint [11] 0 0
Up to ~36 Months
Secondary outcome [12] 0 0
Number of Participants who Discontinued Study Treatment due to AEs
Assessment method [12] 0 0
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 number of participants who discontinued study treatment due to an AE are presented.
Timepoint [12] 0 0
Up to ~34 months
Secondary outcome [13] 0 0
Incidence of Anti-drug Antibodies (ADAs) to Sotatercept
Assessment method [13] 0 0
Blood samples collected at designated timepoints will be used to determine the ADA response to Sotatercept. The incidence of ADAs to Sotatercept over time will be presented.
Timepoint [13] 0 0
Up to ~36 Months

Eligibility
Key inclusion criteria
Eligible participants must meet all of the following criteria to be enrolled in the study:

1. Age = 18 years
2. Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum 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
3. Symptomatic PAH classified as WHO FC II or III
4. 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)
5. 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
6. 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)
7. 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
8. 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
9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
10. Ability to understand and provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if any of the following criteria are met:

1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
2. 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
3. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
4. 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
5. Baseline systolic BP < 90 mmHg at screening
6. Pregnant or breastfeeding women
7. Any of the following clinical laboratory values at the Screening Visit:

* Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (as defined by MDRD equation)
* Serum alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels > 3 × ULN
* Platelet count < 50,000/mm3 (< 50.0 × 109 /L)
8. 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
9. Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
10. History of pneumonectomy
11. Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
12. Stopped receiving any PH chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and digoxin) within 60 days prior to the Screening Visit
13. 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)
14. Untreated more than mild obstructive sleep apnea
15. History of known pericardial constriction
16. History of restrictive or congestive cardiomyopathy
17. History of atrial septostomy within 180 days prior to the Screening Visit
18. Electrocardiogram with Fridericia's corrected QT interval > 500 ms during the Screening Period
19. Personal or family history of long QT syndrome or sudden cardiac death
20. Left ventricular ejection fraction < 50% on historical echocardiogram (ECHO) within 1 year prior to the Screening Visit
21. 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
22. Cerebrovascular accident within 3 months prior to the Screening Visit
23. Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
24. Significant (= 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
26. 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

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital ( Site 1106) - Camperdown
Recruitment hospital [2] 0 0
John Hunter Hospital ( Site 1101) - Newcastle
Recruitment hospital [3] 0 0
Prince Charles Hospital ( Site 1104) - Chermside
Recruitment hospital [4] 0 0
Princess Alexandra Hospital ( Site 1108) - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital ( Site 1109) - Adelaide
Recruitment hospital [6] 0 0
Royal Hobart Hospital ( Site 1107) - Hobart
Recruitment hospital [7] 0 0
Fiona Stanley Hospital ( Site 1103) - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2308 - Newcastle
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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Massachusetts
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Utah
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Santa Fe
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Tirol
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Vienne
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Bayern
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Sachsen
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Berlin
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Monza E Brianza
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Italy
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Napoli
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Roma
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Incheon
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Kyonggi-do
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Seoul
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Waikato
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Poland
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Malopolskie
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Mazowieckie
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Portugal
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Setubal
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Portugal
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Coimbra
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Portugal
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Lisboa
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Serbia
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Juznobacki Okrug
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Serbia
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Nisavski Okrug
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Serbia
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Sumadijski Okrug
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Serbia
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Beograd
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Spain
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Cantabria
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Salamanca
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Spain
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Toledo
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Sweden
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Skane Lan
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Sweden
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Uppsala Lan
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Sweden
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Vasterbottens Lan
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Switzerland
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Zurich
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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United Kingdom
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Cambridgeshire
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United Kingdom
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Derbyshire
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United Kingdom
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Glasgow City
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United Kingdom
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London, City Of
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United Kingdom
State/province [113] 0 0
Newcastle Upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.