Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05587712
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-10-17
Brief Title:
Study to Evaluate Sotatercept MK-7962 in Children With Pulmonary Arterial Hypertension PAH MK-7962-008
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 2 Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Sotatercept MK-7962 in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care
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:
MOONBEAM
Brief Summary:
The primary objectives of the study are to evaluate the safety and tolerability and pharmacokinetics PK of sotatercept over 24 weeks of treatment in children 1 to 18 years of age with PAH World Health Organization WHO Group 1 on standard of care SoC There is no formal hypothesis
Detailed Description:
None
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 |
|---|---|---|---|
| MK-7962-008 | OTHER | None | None |
| 2022-000478-25 | EUDRACT_NUMBER | Merck | None |