Researchers are looking for other ways to treat people in India with pulmonary arterial hypertension (PAH), also known as Group 1 pulmonary hypertension (PH). In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. This causes high blood pressure in the lungs and can overwork the heart. PAH can make it hard to breathe and be active.
Researchers want to learn if sotatercept, the study medicine, can be given with standard treatment to help treat PAH. The standard treatment (the usual treatment) for PAH includes one or multiple medicines. However, these may not fully work or treat the symptoms of PAH in some people.
The goal of this study is to learn about the safety and tolerability of sotatercept when it is given with standard treatment to people in India.
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
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
Single group
Sotatercept
Biological/VaccineAdministered as SC injection
Background PAH Therapy
DrugBackground PAH therapy refers to approved PAH-specific medications and may consist of a single, double, or triple combination of therapy with Endothelin Receptor Antagonists (ERAs), Phosphodiesterase Type 5 Inhibitors (PDE5), soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists
Number of participants who experience an adverse event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of participants who discontinue study intervention due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
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