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

NCT06814145

Active Not RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hypertension, Pulmonary

Interventions: Sotatercept

Countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Mexico

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

\- Completed sotatercept parent study (MK-7962-007\[CADENCE\] \[Visit 9 and EOT visit\] or MK-7962-041 \[P041\] \[EOT Visit\]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
* 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
Locations (57)
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Santa Barbara, California, United States
  • Stanford, California, United States
  • Littleton, Colorado, United States
  • New Haven, Connecticut, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Louisville, Kentucky, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Wynnewood, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Charleston, South Carolina, United States
  • Knoxville, Tennessee, United States
  • Murray, Utah, United States
  • Falls Church, Virginia, United States
  • Richmond, Virginia, United States
  • Brussels, Bruxelles-Capitale, Region de, Belgium
  • Hamilton, Ontario, Canada
  • Nice, Alpes-Maritimes, France
  • Montpellier, Herault, France
  • Saint-Herblain, Loire-Atlantique, France
  • Angers, Maine-et-Loire, France
  • Rouen, Seine-Maritime, France
  • + 27 more on CT.gov