Sotatercept in Indian adults with pulmonary arterial hypertension on standard therapy

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 is a Phase 4 interventional trial evaluating sotatercept combined with background PAH therapy in Indian adults with Group 1 PAH. Eligible participants must have stable background PAH treatments and WHO FC II–III symptoms. The study focuses on safety and tolerability of the combination, alongside standard care. Sites are located in Hyderabad, Belagavi, and Chennai, with Merck Sharp & Dohme LLC as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has documented historical diagnostic right heart catheterization (RHC), with the diagnosis of pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH), in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, and PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
* Has been on stable doses of PAH background therapies and diuretics (if applicable)
* Has symptomatic PAH classified as World Health Organization (WHO) Functional Classification (FC) II or III

Exclusion Criteria:

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

* Has a diagnosis of Groups 2, 3, 4, or 5 PH
* Has a diagnosis of the following PAH (Group 1 PH) subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH, PAH diagnosed with pulmonary veno occlusive disease (PVOD) or pulmonary capillary hemangiomatosis (PCH)
* Has uncontrolled systemic hypertension
* Has a history of full or partial pneumonectomy
* Has untreated more than mild obstructive sleep apnea
* Has known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C
* Has a history of restrictive, constrictive, or congestive cardiomyopathy
* Has significant mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis, and more than mild aortic valve stenosis
* Has known malignancy that is progressing or has required active treatment within the past 5 years

Where it's running

• Renova Century Hospitals ( Site 0011)
  Hyderabad, Andhra Pradesh, India Recruiting
• KLES Dr. Prabhakar Kore Hospital & M.R.C ( Site 0013)
  Belagavi, Karnataka, India Recruiting
• Madras Medical Mission Hospital ( Site 0008)
  Chennai, Tamil Nadu, India Recruiting

Study contacts

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

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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.