Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Official Title

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Details

Participants eligible to enroll in this study will have participated in and completed the requirements of the MK-7962-004 Amendment 07 or later (NCT04796337).

Keywords

Pulmonary Arterial Hypertension, ACE-011, Sotatercept

Eligibility

You can join if…

Open to people ages 18 years and up

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

  • Has completed the MK-7962-004 study requirements
  • Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements

You CAN'T join if...

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

  • Is a female who is pregnant or breastfeeding
  • Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
  • Is currently enrolled in another investigational product study other than a sotatercept study
  • Is incapacitated

Locations

  • University of California San Diego Health ( Site 1002) accepting new patients
    La Jolla California 92039 United States
  • Pulmonary Associates, PA ( Site 1008) accepting new patients
    Phoenix Arizona 85032 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information
ID
NCT07218029
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 815 study participants
Last Updated