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

Description

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.

Conditions

Hypertension, Pulmonary

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Hypertension, Pulmonary
Intervention / Treatment

-

Contacts and Locations

Phoenix

Pulmonary Associates, PA ( Site 1008), Phoenix, Arizona, United States, 85032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-03-30