Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351631
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-02
Brief Title:
A Study to Evaluate Safety and Efficacy of Bomedemstat MK-3543-017
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multicenter Open-Label Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
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:
None
Brief Summary:
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data The study will include participants who are safely tolerating bomedemstat receiving clinical benefit from its use in estimation of the investigator and have shown the following criteria
Participants from the IMG-7289-202MK-3543-005 NCT05223920 study must have received at least 6 months of treatment with bomedemstat
Essential thrombocythemia ET and polycythemia vera PV participants from studies other than IMG-7289-202MK-3543-005 must have achieved confirmed hematologic remission
No hypothesis testing will be conducted in this study
Participants from the IMG-7289-202MK-3543-005 NCT05223920 study must have received at least 6 months of treatment with bomedemstat
Essential thrombocythemia ET and polycythemia vera PV participants from studies other than IMG-7289-202MK-3543-005 must have achieved confirmed hematologic remission
No hypothesis testing will be conducted in this study
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-3543-017 | OTHER | Merck ID | None |
| 2023-506996-89 | OTHER | None | None |
| U1111-1294-8621 | OTHER | None | None |