Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Merck Sharp & Dohme LLC
130 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- \- 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 Criteria8
- 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
Interventions
subcutaneous injection
Locations(55)
View Full Details on ClinicalTrials.gov
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NCT06814145