Pulmonary Arterial Hypertension
Conditions
Brief 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.
Detailed description
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.
Interventions
BIOLOGICALSotatercept
Sotatercept SC injection every 3 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) | Baseline and up to approximately 48 months | The 6MWD is the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD will be reported. |
| Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels | Baseline and up to approximately 48 months | NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels will be reported. |
| 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) | Baseline and up to approximately 48 months | The severity of participant's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform physical activity without any symptoms, dyspnea at rest). Participants will be classified as "Improved", "No change", or "Worsened". Improved = reduction in WHO FC; No Change = no change in WHO FC; Worsened = increase in WHO FC. The change from baseline in the percentage of participants who improve or show maintenance in WHO FC will be reported. |
| Change From Baseline in Pulmonary Vascular Resistance (PVR) | Baseline and up to approximately 48 months | PVR is a hemodynamic variable of pulmonary circulation and is measured by right heart catheterization. The change from baseline in PVR will be reported. |
| Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator | Baseline and up to approximately 48 months | The simplified French Risk scoring system is based on the 2015 European Society of Cardiology/European Respiratory Society guidelines for the diagnosis and treatment of pulmonary hypertension (PH). Noninvasive parameters (WHO FC, 6MWD, NT-proBNP levels) will be used to determine the score. 'Low risk' is defined as maintaining or achieving all 3 low-risk criteria: WHO FC I or II, 6MWD \>440 meters, and NT-proBNP \<300 ng/L. The change from baseline in percentage of participants who maintain or achieve a low risk simplified French Risk score will be reported. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed