A Study of Sotatercept for Pulmonary Arterial Hypertension (PAH)
This study is looking into sotatercept (MK-7962), a targeted therapy designed to treat pulmonary arterial hypertension (PAH). PAH is a condition where blood vessels in the lungs become narrow, making it hard for blood to flow and causing high blood pressure in the lungs. Sotatercept works on specific proteins involved in causing PAH. This is a long-term follow-up study for people who have already participated in certain other studies testing sotatercept for PAH. The study aims to track side effects, how many people stop treatment due to side effects, and if participants develop antibodies to the medicine over several years. The study plans to enroll 815 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 815 participants. It is a long-term follow-up study for individuals who previously participated in other sotatercept studies for PAH.
- What's involved
- Participants will receive sotatercept as an injection under the skin every 3 weeks. You must be willing to follow the study visit schedule and all protocol requirements.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to approximately 90 months to monitor for adverse events, up to 86 months for discontinuing treatment due to adverse events, and up to 88 months for anti-drug antibodies.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
At a glance
Conditions
NCT07218029
Where you'd take part
This study runs at 136 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizonastudy coordinator listed
Recruiting
Brigham and Women's Hospital ( Site 1014)
Boston, Massachusettsstudy coordinator listed
Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice, Alpes-Maritimes, Francestudy coordinator listed
Recruiting
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
Saint-Étienne-de-Montluc, Pays de la Loire Region, Francestudy coordinator listed
Recruiting
CHU Bordeaux Haut-Leveque ( Site 1312)
Pessac, Aquitaine, Francestudy coordinator listed
Recruiting
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers, Vienne, Francestudy coordinator listed
Recruiting
Hopital Cavale Blanche ( Site 1314)
Brest, Finistere, Francestudy coordinator listed
Recruiting
Hôpital Louis Pradel ( Site 1317)
Lyon, Rhone, Francestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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 AEUp 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 HemoglobinUp 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 WeightBaseline and up to approximately 86 months
Change from baseline in body weight will be reported.
- Change From Baseline in Blood PressureBaseline 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.