Spots Global Cancer Trial Database for A Study to Evaluate P1101 in Japanese PV Patients

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Trial Identification

Brief Title: A Study to Evaluate P1101 in Japanese PV Patients

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).

Study ID: NCT06002490

Conditions

Polycythemia Vera (PV)

Interventions

P1101

Low-dose aspirin

Phlebotomy

Study Description

Brief Summary: This is a Phase 3 single arm study to investigate efficacy and safety of P1101's 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 10\^9/L), and PLT (≤400 x 10\^9/L).