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

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

Duke University Medical Center ( Site 1026)
Durham, North Carolina 27710-4000
Contact:
Study Coordinator
919-681-8439

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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