Instituto Medico Rio Cuarto | Research Center | Rio Cuarto, Argentina
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About
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.
Full 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.
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Inclusion criteria
Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Females of childbearing potential must:
Male participants must:
Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study
Exclusion criteria
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700 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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