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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sotatercept 		Participants enrolling from the MK-7962-004 sotatercept study will continue sotatercept at their current dose. If currently at a dose <0.7 mg/kg subcutaneous (SC) injection, participants can titrate up to 0.7 mg/kg SC injection for the remainder of this study.
  • Biological: Sotatercept
    Sotatercept SC injection at a dose of 0.3 to 0.7 mg/kg
    Other names:
    • MK-7962
    • ACE-011
    • ActRIIA-IgG1Fc
    • WINREVAIR®

Recruiting Locations

Pulmonary Associates, PA ( Site 1008)
Phoenix 5308655, Arizona 5551752 85032
Contact:
Study Coordinator
602-346-4747

University of California San Diego Health ( Site 1002)
La Jolla 5363943, California 5332921 92039
Contact:
Study Coordinator
858-657-7150

University of Colorado Hospital ( Site 1013)
Aurora 5412347, Colorado 5417618 80045
Contact:
Study Coordinator
720-848-5300

Weill Cornell Medical Center ( Site 1046)
New York 5128581, New York 5128638 10021
Contact:
Study Coordinator
646-962-5555

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Study Coordinator
513-585-1777

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.