Pulmonary arterial hypertension
Conditions
Brief summary
Serum Trough Concentration (Ctrough) of Sotatercept, Area Under the Curve at Steady State (AUCss) of Sotatercept, Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept, Percentage of Participants Who Experience at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Drug Due to an AE, Laboratory Parameter (Hematology): Concentration of Hemoglobin, Laboratory Parameter (Hematology): Hematocrit, Laboratory Parameter (Hematology): RBC Count, Laboratory Parameter (Hematology): Reticulocyte Count, Laboratory Parameter (Hematology): Platelet Count, Blood Pressure (BP), Titer of Anti-drug Antibody (ADA) to Sotatercept
Detailed description
Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE), Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP), Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC), Mean Change from Baseline in Eccentricity Index, Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2), Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2), Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2), Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score, Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP), Percentage of Participants who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Trough Concentration (Ctrough) of Sotatercept, Area Under the Curve at Steady State (AUCss) of Sotatercept, Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept, Percentage of Participants Who Experience at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Drug Due to an AE, Laboratory Parameter (Hematology): Concentration of Hemoglobin, Laboratory Parameter (Hematology): Hematocrit, Laboratory Parameter (Hematology): RBC Count, Laboratory Parameter (Hematology): Reticulocyte Count, Laboratory Parameter (Hematology): Platelet Count, Blood Pressure (BP), Titer of Anti-drug Antibody (ADA) to Sotatercept | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2), Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE), Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP), Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC), Mean Change from Baseline in Eccentricity Index, Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2), Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2), Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2), Mean Change from Baseline in Pediatric Quality of Life (PedsQL) Generic Score, Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP), Percentage of Participants who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC) | — |
Countries
France, Germany, Netherlands, Poland, Spain