Clinical Trials List
Protocol NumberA011-12, MK-7962-004 (SOTERIA)
NCT Number(ClinicalTrials.gov Identfier)NCT04796337
Active
2022-06-01 - 2026-02-27
Phase III
Recruiting3
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-7962-004)
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Sponsor
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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
Co-Principal Investigator
- 戴以信 Division of Emergency Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chih-Hsin Hsu
Co-Principal Investigator
- Po-Sheng Chen Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pulmonary Arterial Hypertension
Objectives
The objective of this trial is to evaluate the long-term safety and tolerability of adding sotatercept to background PAH therapy in adult participants with PAH who received sotatercept or placebo in the parent sotatercept trial, and to assess sustained efficacy.
Test Drug
凍晶乾粉注射劑
Active Ingredient
Sotatercept
Dosage Form
247
Dosage
mg/vial
Endpoints
The following indicators will be assessed as measures of safety and tolerability:
• Adverse events (AEs)
• Anti-drug antibodies (ADAs)
• Clinical laboratory assessments (hematology and chemistry)
• Vital signs
• 12-lead electrocardiogram (ECG)
• Adverse events (AEs)
• Anti-drug antibodies (ADAs)
• Clinical laboratory assessments (hematology and chemistry)
• Vital signs
• 12-lead electrocardiogram (ECG)
Inclution Criteria
Inclusion Criteria:
Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Females of childbearing potential must:
Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug
Male participants must:
Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study, except for the MK-7962-038 study
Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Females of childbearing potential must:
Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug
Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug
Male participants must:
Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug
Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study, except for the MK-7962-038 study
Exclusion Criteria
Exclusion Criteria:
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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
Pregnant or breastfeeding females
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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
Pregnant or breastfeeding females
The Estimated Number of Participants
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Taiwan
11 participants
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Global
815 participants
