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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Summary

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

Clinical Trial Description

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04796337
Study type Interventional
Source Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Status Recruiting
Phase Phase 3
Start date May 12, 2021
Completion date November 30, 2027
View Details
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