Clinical Trials List
Protocol NumberMK-7962-038
NCT Number(ClinicalTrials.gov Identfier)NCT07218029
Active
2025-09-15 - 2031-12-31
Phase III
Recruiting2
ICD-10I27.0
Primary pulmonary hypertension
ICD-9416.0
Primary pulmonary hypertension
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chih-Hsin Hsu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pulmonary Arterial Hypertension
Objectives
To evaluate the long-term safety and tolerability of sotatercept.
Test Drug
Injectables
Active Ingredient
SOTATERCEPT
Dosage Form
270
270
270
Dosage
45 mg/vial 1 vial/kit
60 mg/vial 1 vial/kit
60 mg/vial 1 vial/kit
Endpoints
Adverse events; Anti-drug antibodies (ADA); Clinical laboratory assessment (hematology, chemistry); Vital signs; 12-lead electrocardiogram (ECG)
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has completed the MK-7962-004 study requirements
Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
The main inclusion criteria include but are not limited to the following:
Has completed the MK-7962-004 study requirements
Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Is a female who is pregnant or breastfeeding
Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Is currently enrolled in another investigational product study other than a sotatercept study
Is incapacitated
The main exclusion criteria include but are not limited to the following:
Is a female who is pregnant or breastfeeding
Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Is currently enrolled in another investigational product study other than a sotatercept study
Is incapacitated
The Estimated Number of Participants
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Taiwan
3 participants
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Global
815 participants
