Long-term sotatercept treatment for people with pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This long-term follow-up enrolls people who completed prior sotatercept PAH trials to continue receiving sotatercept alongside their standard PAH medicines. Participants will attend regular clinic visits for monitoring of adverse events, laboratory tests, and overall tolerability over an extended period. The primary aim is to collect long-term safety and tolerability data rather than to compare efficacy against a control. Enrollment is restricted to those who did not discontinue their parent study and who meet routine eligibility checks such as pregnancy status and recent dosing history.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
  Santa Barbara, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
  Torrance, California, United States Recruiting
• Mayo Clinic Jacksonville ( Site 1045)
  Jacksonville, Florida, United States Recruiting
• AdventHealth Orlando ( Site 1058)
  Orlando, Florida, United States Recruiting
• University of Kansas Medical Center ( Site 1020)
  Kansas City, Kansas, United States Recruiting
• Norton Pulmonary Specialists ( Site 1066)
  Louisville, Kentucky, United States Recruiting

+57 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sotatercept in Japanese children with pulmonary arterial hypertension

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  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07613099

• Sotatercept in Indian adults with pulmonary arterial hypertension on standard therapy

  This study tests whether adding sotatercept to current PAH medicines is safe and tolerable for adults with PAH in India.

  Recruiting at 3 sites Phase 4 Merck Sharp & Dohme LLC · Hyderabad, Andhra Pradesh and 2 other locations · NCT07600723

• Once-daily treprostinil palmitil inhalation powder for PAH

  This study tests whether taking a daily inhaled treprostinil palmitil powder for 24 weeks improves exercise ability in adults with pulmonary arterial hypertension compared to a placebo.

  Recruiting at 39 sites Phase 3 Insmed Incorporated · Los Angeles, California and 38 other locations · NCT07481981

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.