Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002490
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-07-31
Brief Title:
A Study to Evaluate P1101 in Japanese PV Patients
Sponsor:
PharmaEssentia Japan KK
Organization:
PharmaEssentia Japan KK
Study Overview
Official Title:
A Phase III b Single-arm Multicenter Optimal Dose Finding Study to Assess the Efficacy and Safety of P1101 in Japanese Patients With Polycythemia Vera PV
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This is a Phase 3 single arm study to investigate efficacy and safety of P1101s rapid titration for adult Japanese patients with PV
Detailed Description:
Eligible patients will be treated with P1101 starting at 250 μg A starting dose of P1101 is 250 mcg an intermediate dose is 350 mcg and a target dose is 500 mcg As such subjects will not be exposed to below optimal doses within the first 4 weeks The maximum recommended single dose is 500 μg injected every two weeks
A primary efficacy endpoint is the rate of phlebotomy-free complete hematologic response CHR at Week 24 where CHR is defined as the proportion of patients who have achieved a CHR and have not required phlebotomy in the previous 12 weeks A responder for the primary endpoint is defined as meeting all of the following criteria at Week 24 Hct 45 WBC 10 x 109L and PLT 400 x 109L
A primary efficacy endpoint is the rate of phlebotomy-free complete hematologic response CHR at Week 24 where CHR is defined as the proportion of patients who have achieved a CHR and have not required phlebotomy in the previous 12 weeks A responder for the primary endpoint is defined as meeting all of the following criteria at Week 24 Hct 45 WBC 10 x 109L and PLT 400 x 109L
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