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A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

UCI Specialty Areas: Cardiology, Pulmonology
Principal Investigator: Bassam Yaghmour
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-7962-004)
A Study On:
Lung - Pulmonary
Pulmonary Arterial Hypertension PAH

Study Description

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.

Eligibility

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

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

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

  1. Did not participate in a sotatercept PAH parent study
  2. Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  3. 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
  4. Is a female who is pregnant or breastfeeding
  5. Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
  6. Is currently enrolled in another investigational product study other than a sotatercept study
  7. Is incapacitated
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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