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
2026/04/10
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 antibody (ADA)
Clinical laboratory assessment (hematology, chemistry)
Vital signs
12-lead electrocardiogram (ECG)
Anti-drug antibody (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 their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
The main inclusion criteria include but are not limited to the following:
Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Did not participate in a sotatercept PAH parent study
Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
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:
Did not participate in a sotatercept PAH parent study
Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
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
