Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456346
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-07
Brief Title:
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia MK-3543-007
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat MK-3543 Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants
Status:
RECRUITING
Status Verified Date:
2024-10
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 purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia ET participants for whom cytoreductive therapy is indicated Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response DCHR The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to 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 |
|---|---|---|---|
| MK-3543-007 | OTHER | Merck | None |
| 2023-505232-36 | OTHER | None | None |
| jRCT2031240181 | REGISTRY | None | None |