P1101

DRUG3 trials

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie, PharmaEssentia Japan K.K.

Conditions

Chronic Phase Chronic Myeloid LeukemiaPolycythemia Vera (PV)

Phase 1

Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response

CompletedNCT01933906

Arbeitsgemeinschaft medikamentoese TumortherapieChronic Phase Chronic Myeloid Leukemia

Start: 2013-08-30End: 2018-11-14Updated: 2019-01-04

Phase 2

Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply

CompletedNCT04182100

PharmaEssentia Japan K.K.Polycythemia Vera (PV)

Start: 2019-12-20End: 2021-03-08Updated: 2025-09-15

Phase 3

A Study to Evaluate P1101 in Japanese PV Patients

CompletedNCT06002490

PharmaEssentia Japan K.K.Polycythemia Vera (PV)

Start: 2023-10-17End: 2024-07-26Updated: 2024-11-08

Related Papers

Efficacy and safety of a three-step dose escalation regimen of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: a phase 3b, single-arm, multicenter study.

2026-03-09

Population Pharmacokinetics‐Pharmacodynamics and Exposure‐Response of Ropeginterferon Alfa‐2b in Chinese and Japanese Patients With Polycythemia Vera

Pharmacology Research & Perspectives2025-05-015 citations

P1007: PHASE 2, OPEN-LABEL, MULTICENTER, SINGLE-ARM STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ROPEGINTERFERON ALFA-2B IN JAPANESE PATIENTS WITH POLYCYTHEMIA VERA

HemaSphere2022-06-01

The Rationale, Design, and Baseline Characteristics of a Phase 2 Study to Evaluate the Safety and Efficacy of Ropeginterferon Alfa-2b (P1101) in Japanese Patients with Polycythemia Vera for Whom the Current Standard of Care Is Difficult to Apply

Blood2020-11-042 citations