A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Condition(s) studied

Investigational drug(s) / intervention(s)

Sotatercept: Sotatercept SC injection every 3 weeks

Study summary

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Eligibility

Primary outcome measure(s)

• Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 90 months
  An AE 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. The number of participants who experience an AE will be reported.
• Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 86 months
  An AE 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. The number of participants who discontinue study treatment due to an AE will be reported.
• Number of Participants with Detectable Anti-Drug Antibodies (ADAs) — Up to approximately 88 months
  ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.
• Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin — Up to approximately 88 months
  Blood samples will be collected to determine the concentration of platelets and hemoglobin.
• Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) — Up to approximately 86 months
  Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.
• Change From Baseline in Body Weight — Baseline and up to approximately 86 months
  Change from baseline in body weight will be reported.
• Change From Baseline in Blood Pressure — Baseline and up to approximately 86 months
  Change from baseline in systolic and diastolic blood pressure will be reported.
• Change From Baseline in Electrocardiogram (ECG) — Baseline and up to approximately 86 months
  Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.

Trial sites (136)

+ 96 more sites — see the full list on the official registry below.