Trial · NCT05587712
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Trough Concentration (Ctrough) of Sotatercept | Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76 | Ctrough was the lowest concentration of Sotatercept in serum just before the next dose. Blood samples will be collected at multiple time points to estimate the Ctrough of Sotatercept. |
| Primary | Area Under the Curve at Steady State (AUCss) of Sotatercept | Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76 | Blood samples will be collected at multiple time points to estimate the AUCss of Sotatercept. |
| Primary | Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept | Predose Day 1, Day 7, Day 14, and Predose Day 21 | Blood samples will be collected at Predose Day 1, Day 7, Day 14, and Predose Day 21 to estimate the AUC0-3 weeks of Sotatercept. |
| Primary | Percentage of Participants Who Experience at Least 1 Adverse Event (AE) | Up to 24 weeks | An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs will be assessed. |
| Primary | Percentage of Participants Who Discontinue Study Drug Due to an AE | Up to 24 weeks | An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study drug due to an AE regardless of study completion status will be assessed. |
| Primary | Laboratory Parameter (Hematology): Concentration of Hemoglobin | Up to 24 weeks | Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented. |
| Primary | Laboratory Parameter (Hematology): Hematocrit | Up to 24 weeks | Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented. |
| Primary | Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count | Up to 24 weeks | Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented. |
| Primary | Laboratory Parameter (Hematology): Reticulocyte Count | Up to 24 weeks | Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented. |
| Primary | Laboratory Parameter (Hematology): Platelet Count | Up to 24 weeks | Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented. |
| Primary | Blood Pressure (BP) | Up to 24 weeks | BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones). |
| Primary | Titer of Anti-drug Antibody (ADA) to Sotatercept | Up to 24 weeks | ADA to Sotatercept will be assessed. |
| Secondary | Mean Change from Baseline in 6-Minute Walk Distance (6MWD) (Cohorts 1 and 2) | Baseline and Week 24 | 6MWD will be assessed using the 6-minute walk test (6MWT). |
| Secondary | Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) | Baseline and Week 24 | A two-dimensional echocardiogram (ECHO) will be performed with the results interpreted by a blinded independent central review (BICR) at baseline and after 24 weeks of treatment. The change from baseline in TAPSE will be reported. |
| Secondary | Mean Change from Baseline in Pulmonary Artery Systolic Pressure (PASP) | Baseline and Week 24 | A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in PASP will be reported. |
| Secondary | Mean Change from Baseline in Right Ventricular Fractional Area Change (RVFAC) | Baseline and Week 24 | A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in RVFAC will be reported. |
| Secondary | Mean Change from Baseline in Eccentricity Index | Baseline and Week 24 | A two-dimensional ECHO will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in eccentricity index will be reported. |
| Secondary | Mean Change from Baseline in Right Ventricular (RV) Function (Cohorts 1 and 2) | Baseline and Week 24 | Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in eccentricity index will be reported. |
| Secondary | Mean Change from Baseline on Cardiac Output (Cohorts 1 and 2) | Baseline and Week 24 | Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in cardiac output will be reported. |
| Secondary | Mean Change from Baseline in Pulmonary Arterial Pressure (PAP) (Cohorts 1 and 2) | Baseline and Week 24 | Cardiac magnetic imaging (MRI) will be performed with the results interpreted by a BICR at baseline and after 24 weeks of treatment. The change from baseline in PAP will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05587712/registered