A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Purpose
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.
Condition
- Pulmonary Arterial Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 exclusion criteria include but are not limited to the following: - Did not participate in a sotatercept PAH parent study - Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. - Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept - Is a female who is pregnant or breastfeeding - Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study - Is currently enrolled in another investigational product study other than a sotatercept study - Is incapacitated
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sotatercept |
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose <0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. |
|
Recruiting Locations
Orange, California 92868
Study Coordinator
949-824-9320
Santa Barbara, California 93105-5316
Study Coordinator
805-845-1500
Orlando, Florida 32803
Study Coordinator
407-303-7556
Kansas City, Kansas 66160
Study Coordinator
913-588-3855
Louisville, Kentucky 40202
Study Coordinator
502-587-8000
Baltimore, Maryland 21287
Study Coordinator
410-614-6311
Boston, Massachusetts 02111
Study Coordinator
617-636-6304
Durham, North Carolina 27710-4000
Study Coordinator
919-668-2642
Cincinnati, Ohio 45219
Study Coordinator
513-585-1777
Cincinnati, Ohio 45219
Study Coordinator
513-558-4831
Pittsburgh, Pennsylvania 15213
Study Coordinator
412-692-2769
Providence, Rhode Island 02903
Study Coordinator
401-444-2733
Charleston, South Carolina 29425
Study Coordinator
843-792-0965
Dallas, Texas 75390
Study Coordinator
214-645-5055
Houston, Texas 77030
Study Coordinator
713-798-6230
Houston, Texas 77030
Study Coordinator
713-441-7182
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
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.