Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

Purpose

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Condition

  • Hypertension, Pulmonary

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

The main inclusion criteria include but are not limited to the following: - Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment [EOT] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5 - Has had a study intervention interruption - Is pregnant or breastfeeding - Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy) - Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair - Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction) - Anticipated or undergone heart transplant or ventricular assist device implantation - Has had prior exposure to luspatercept

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sotatercept 0.3 mg/kg 		Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.
  • Biological: Sotatercept
    subcutaneous injection
    Other names:
    • ACE-011
Experimental
Sotatercept 0.7 mg/kg 		Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.
  • Biological: Sotatercept
    subcutaneous injection
    Other names:
    • ACE-011

Recruiting Locations

Pulmonary Associates, PA ( Site 1008)
Phoenix 5308655, Arizona 5551752 85032
Contact:
Study Coordinator
888-577-8839

The Emory Clinic ( Site 1030)
Atlanta 4180439, Georgia 4197000 30322
Contact:
Study Coordinator
404-712-8204

Weill Cornell Medical Center ( Site 1046)
New York 5128581, New York 5128638 10065
Contact:
Study Coordinator
646-962-5555

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Study Coordinator
513-585-1777

Inova Heart and Vascular Institute ( Site 1078)
Falls Church 4758390, Virginia 6254928 22042
Contact:
Study Coordinator
703-776-2828

Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
Richmond 4781708, Virginia 6254928 23230
Contact:
Study Coordinator
8043204243x3533

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com