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 UC Irvine UCLA UCSD UCSF
- Dates
- study startedstudy 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
- University of California San Diego Health ( Site 1002)
in progress, not accepting new patients
La Jolla California 92039 United States - UC Irvine Health Medical Center ( Site 1086)
accepting new patients
Orange California 92868 United States - UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
in progress, not accepting new patients
San Francisco California 94143 United States - Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
in progress, not accepting new patients
Torrance California 90502 United States - Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
accepting new patients
Santa Barbara California 93105-5316 United States
Details
- Status
- accepting new patients
- 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
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