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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521970-33-00
Acronym
MK-7962-038
Enrollment
389
Registered
2025-12-01
Start date
2025-12-19
Completion date
Unknown
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

​​Pulmonary Arterial Hypertension (PAH)

Brief summary

Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants With Detectable Anti-drug Antibodies (ADAs), Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit, Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin, Change From Baseline in Body Weight, Change From Baseline in Blood Pressure, Change From Baseline in Electrocardiogram (ECG)

Detailed description

Change From Baseline in 6-Minute Walk Distance (6MWD), Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels, Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC), Change From Baseline in Pulmonary Vascular Resistance (PVR), Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator

Interventions

DRUGSOTATERCEPT
DRUGsotatercept

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants With Detectable Anti-drug Antibodies (ADAs), Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit, Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin, Change From Baseline in Body Weight, Change From Baseline in Blood Pressure, Change From Baseline in Electrocardiogram (ECG)

Secondary

MeasureTime frame
Change From Baseline in 6-Minute Walk Distance (6MWD), Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels, Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC), Change From Baseline in Pulmonary Vascular Resistance (PVR), Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator

Countries

Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026