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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7962-032 | Other Identifier | MSD |
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The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept | Experimental | Participants receive sotatercept by subcutaneous injection every 3 weeks (Q3W) for up to approximately 24 weeks while continuing standard-of-care background therapy for PAH. Participants start at a dose of 0.3 mg/kg Q3W, and may titrate up to the target dose of 0.7 mg/kg SC injection Q3W starting at Week 6 based on protocol-defined dose-escalation guidance. After Week 24, participants who meet certain requirements may choose to continue receiving sotatercept for up to 58 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | Sotatercept subcutaneous injection every 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 24 weeks |
| Number of Participants Who Discontinue Study Intervention Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 24 weeks |
| Laboratory Parameter (Hematology): Concentration of Hemoglobin | 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. | Up to approximately 24 weeks |
| Laboratory Parameter (Hematology): Hematocrit | 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. | Up to approximately 24 weeks |
| Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count | 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. | Up to approximately 24 weeks |
| Laboratory Parameter (Hematology): Reticulocyte Count |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in 6-Minute Walk Distance (6MWD) | 6MWD will be assessed using the 6-minute walk test (6MWT). | Baseline and Week 24 |
| Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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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.
| Up to approximately 24 weeks |
| Laboratory Parameter (Hematology): Platelet Count | 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. | Up to approximately 24 weeks |
| Blood Pressure (BP) | 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). | Up to approximately 24 weeks |
| Number of Participants with Detectable Anti-Drug Antibodies (ADAs) | Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented. | Up to approximately 24 weeks |
| Number of Participants with Detectable Neutralizing Antibodies to Sotatercept | Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented. | Up to approximately 24 weeks |
| Serum Trough Concentration (Ctrough) of Sotatercept | Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept. | At designated time points and up to approximately 24 weeks |
| Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) | The change from baseline in PVRI will be presented. | Baseline and Week 24 |
The change from baseline in plasma NT-proBNP levels will be reported.
| Baseline and Week 24 |
| Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC) | The severity of an individual's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC will be classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. | Baseline and Week 24 |
| Number of Participants With One or More Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | From Week 24 up to approximately 58 months |
| Number of Participants Who Discontinue Study Intervention Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | From Week 24 up to approximately 58 months |
| Laboratory Parameter (Hematology): Concentration of Hemoglobin | 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. | From Week 24 up to approximately 58 months |
| Laboratory Parameter (Hematology): Hematocrit | 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. | From Week 24 up to approximately 58 months |
| Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count | 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. | From Week 24 up to approximately 58 months |
| Laboratory Parameter (Hematology): Reticulocyte Count | 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. | From Week 24 up to approximately 58 months |
| Laboratory Parameter (Hematology): Platelet Count | 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. | From Week 24 up to approximately 58 months |
| Blood Pressure (BP) | 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). | From Week 24 up to approximately 58 months |
| Number of Participants with Detectable ADAs | Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented. | From Week 24 up to approximately 58 months |
| Number of Participants with Detectable Neutralizing Antibodies to Sotatercept | Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as ADA-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented. | From Week 24 up to approximately 58 months |