Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04796337
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-02-22
Brief Title:
A Long-term Follow-up Study of Sotatercept for PAH Treatment MK-7962-004A011-12
Sponsor:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Organization:
Acceleron Pharma Inc a wholly-owned subsidiary of Merck Co Inc Rahway NJ USA
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOTERIA
Brief Summary:
This study is being conducted to assess the long-term safety tolerability and efficacy of sotatercept MK-7962 formerly called ACE-011 in participants with Pulmonary Arterial Hypertension PAH This open-label long-term follow-up LTFU study is supported by data from the PULSAR study Phase 2 NCT03496207 in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants including those receiving maximal PAH therapy with doubletriple drug combinations and intravenous prostacyclin
The primary objective of this open-label LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies
The primary objective of this open-label LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies
Detailed Description:
Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A011-12 | OTHER | None | None |
| 2020-005061-13 | EUDRACT_NUMBER | Acceleronpharma | None |