Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079879
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-10-06
Brief Title:
A Study of Bomedemstat IMG-7289MK-3543 Compared to Best Available Therapy BAT in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea MK-3543-006
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat MK-3543IMG-7289 Versus Best Available Therapy BAT in Participants With Essential Thrombocythemia Who Have an Inadequate Response to or Are Intolerant of Hydroxyurea
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:
This is a study evaluating the safety and efficacy of bomedemstat MK-3543 compared with the best available therapy BAT in participants with essential thrombocythemia ET who have an inadequate response to or are intolerant of hydroxyurea
The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response DCHR
The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response DCHR
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 |
|---|---|---|---|
| 2023-504865-21 | OTHER | None | None |
| IMG-7289-CTP-301 | OTHER | None | None |
| MK-3543-006 | OTHER | None | None |
| jRCT2031230658 | REGISTRY | Japan Registry of Clinical Trials jRCT | None |