Health Condition 1: I270- Primary pulmonary hypertension
Conditions
Interventions
Intervention1: MK7962 (Sotatercept): Dose:60 mg/vial or 45mg/vial
Dosage level 0.3 mg/kg, subcutaneous (SC), Q3W, starting
at V2
Intervention2: MK7962 (Sotatercept): Dose:60 mg/vial or 45mg/vial
Dosage level 0.7 mg/kg, subcutaneous (SC), Q3W, V3 to EOT
Control Intervention1: NA: NA
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
Eligibility
Inclusion criteria
Inclusion criteria: An individual is eligible for inclusion in the study if the individual meets all of the following criteria: Is an individual of any sex or gender of at least 18 years of age at the time of providing the informed consent. Documented historical right heart catheterization (RHC) showing: PVR more than or equal to 5 WU PCWP or LVEDP less than or equal to 15 mm Hg - Diagnosis of PAH (Group 1 PH) in one of the following subtypes: Idiopathic PAH Heritable PAH Drug/toxin induced PAH PAH associated with connective tissue disease PAH associated with simple congenital systemic to pulmonary shunts (more than or equal to 1 year post repair) Stable doses of PAH background therapies and diuretics (if applicable) for more than or equal to 90 days prior to screening Prostacyclin infusion dose adjustment within 10 percent allowed Symptomatic PAH classified as WHO Functional Class II or III Participants Assigned Male Sex at Birth - If capable of producing sperm: Must use required contraception during treatment and for 16 weeks (112 days) after last dose Must use penile or external condom during penile vaginal intercourse If partner is pregnant or breastfeeding - condom use required during any sexual activity involving potential ejaculative exposure Contraception must follow local regulatory requirements Azoospermic individuals (vasectomy or medical cause) are exempt if confirmed Participants Assigned Female Sex at Birth - Eligible if not pregnant or breastfeeding AND: Not a POCBP, or Is a POCBP and: Uses highly effective contraception plus barrier method, or practices consistent sexual abstinence Continues contraception for 16 weeks (112 days) post last dose Has negative pregnancy test within required window before first dose Agrees to abstain from breastfeeding during treatment and 16 weeks after last dose Medical and sexual history reviewed to minimize risk of enrolling early pregnancies Able and willing to comply with study visits, procedures, labs, and communication (phone or email) Females assigned at birth: refrain from donating blood, eggs or ovum during study and 16 weeks post last dose Males assigned at birth: refrain from donating blood or sperm during study and 16 weeks post last dose
Exclusion criteria
Exclusion criteria: An individual must be excluded from the study if the individual meets any of the following criteria: Pulmonary Hypertension -Diagnosis of PH Groups 2, 3, 4, or 5. -Group 1 PAH subtypes excluded: HIV associated PAH Portal hypertension associated PAH Schistosomiasis associated PAH PVOD (pulmonary veno occlusive disease) PCH (pulmonary capillary hemangiomatosis) Cardiovascular Conditions Uncontrolled hypertension: SBP more than 160 mmHg or DBP more than 100 mmHg. Low systolic BP: less than 90 mmHg. History of full or partial pneumonectomy. QTcF more than 500 ms on ECG. LVEF less than 55percent or diastolic dysfunction more than equal to Grade 3. Coronary artery disease within 6 months (MI, PCI, CABG, angina). CVA within 3 months. Acute decompensated heart failure within 30 days. Significant valvular disease: - more than equal to 2+ mitral or aortic regurgitation - Mitral stenosis - More than mild aortic stenosis Personal or family history of long QT syndrome. History of restrictive, constrictive, or congestive cardiomyopathy. Eisenmenger syndrome or atrial septostomy within 180 days. Pulmonary & Sleep Disorders FVC less than 60percent predicted within past 12 months. Untreated more than mild obstructive sleep apnea. Liver & Renal Conditions Portal hypertension or chronic liver disease (Child Pugh A C). eGFR less than 30 mL/min/1.73m . ALT, AST, or total bilirubin more than 3 ULN. Hematologic Abnormalities Hemoglobin above gender specific ULN. Platelet count less than 50,000/mm . Oncology Active or progressing malignancy within 5 years (except basal or squamous skin cancers or certain carcinoma in situ). Prior or Concomitant Therapies IV inotropes (dobutamine, dopamine, norepinephrine, vasopressin) within 30 days. Prior exposure or allergy to activin signaling inhibitors (sotatercept, luspatercept, cibotercept). Other Clinical Study Restrictions Participation in another investigational study within: - 30 days for small molecules - 5 half-lives for biologics Laboratory Criteria Hemoglobin above ULN. Platelets less than 50,000/mm . Renal or hepatic lab abnormalities defined above. Other Exclusions Pregnant or breastfeeding. Severe medical condition that increases study risk or affects results. Immediate family member of study site or sponsor staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of sotatercept Timepoint: over 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed