Pulmonary Arterial Hypertension (PAH)
Conditions
Brief summary
The primary efficacy endpoint is the time to first event of all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours.
Detailed description
Overall survival Transplant-free survival Proportion of participants with mortality event at EOS Change from BL in REVEAL Lite 2.0 risk score -Wk 24 Proportion of participants achieved REVEAL Lite 2.0 risk score ≤ 7-Wk 24 Change from BL in NT-proBNP levels -Wk 24 Change from BL in mPAP -Wk 24 Change from BL in PVR -Wk 24, Proportion of participants improved in WHO FC at end of DBPC Tx Period Change from BL in 6MWD -Wk 24 Change from BL in CO -Wk 24 Change from BL in EQ-5D-5L index score -Wk 24
Interventions
DRUGPL1 - Lyophilisate and solvent for solution for injection
DRUGsotatercept
Sponsors
Acceleron Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the time to first event of all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Transplant-free survival Proportion of participants with mortality event at EOS Change from BL in REVEAL Lite 2.0 risk score -Wk 24 Proportion of participants achieved REVEAL Lite 2.0 risk score ≤ 7-Wk 24 Change from BL in NT-proBNP levels -Wk 24 Change from BL in mPAP -Wk 24 Change from BL in PVR -Wk 24, Proportion of participants improved in WHO FC at end of DBPC Tx Period Change from BL in 6MWD -Wk 24 Change from BL in CO -Wk 24 Change from BL in EQ-5D-5L index score -Wk 24 | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed