New hope for PAH patients? india study tests sotatercept safety
NCT ID NCT07600723
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study tests the safety of a new medicine called sotatercept for adults in India with pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs become narrow, making breathing hard. About 30 people will receive sotatercept along with their usual treatments. The goal is to see if adding sotatercept is safe and tolerable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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