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A Long-term Follow-up Study of Sotatercept for PAH Treatment
||An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
||Harrison Farber, MD
This is a Phase 3, open-label, follow-up study to evaluate the long-term safety and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the PAH sotatercept clinical studies. Participants who have discontinued from a previous PAH sotatercept clinical study will not be eligible to enroll in this LTFU study.
- Participants must have completed their current respective PAH sotatercept clinical study, must have completed the parent study requirements, and must not have discontinued early.
- Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.
- Participants must have the ability to understand and provide written informed consent.
- Not enrolled in a PAH parent study at the time of enrollment.
- 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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
Patients will be in this study for about 4 years. They will come to come clinic at least every 3 months and take the study drug about every 3 weeks. Patients will get blood drawn 5 times over the first 3 months and then about every 3 months and at follow-up visit. The estimated amount of blood is 10.8 teaspoons. The total amount of blood collected is expected to be 45.9 teaspoons. There will be Right Heart Catheterizations both at the beginning and end of the study. There is an electrocardiogram every 6 months and an echocardiogram done at the 2 year visit.