Not currently recruiting at UCSF

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

a study on High Blood Pressure Pulmonary Arterial Hypertension Pulmonary Hypertension

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
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

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

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 their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
  • Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
  • Must have the ability to understand and provide documented informed consent

You CAN'T join if...

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

  • Did not participate in a sotatercept PAH parent study
  • Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  • Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • 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

  • UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) in progress, not accepting new patients
    San Francisco California 94143 United States
  • Jeffrey S. Sager, MD Medical Corporation ( Site 1060) accepting new patients
    Santa Barbara California 93105-5316 United States
  • UC Irvine Health Medical Center ( Site 1086) accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Plain Language Summary
ID
NCT07218029
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 815 study participants
Last Updated