RecruitingPhase 3NCT04655092

Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)

Sponsor

PharmaEssentia Japan K.K.

Enrollment

67 participants

Start Date

Jan 19, 2021

Study Type

INTERVENTIONAL

Conditions

Polycythemia Vera (PV)

Summary

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

Eligibility

Min Age: 20 Years

Inclusion Criteria2

Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
Patients who have given written informed consent to participate in this study

Exclusion Criteria1

Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101

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Interventions

BIOLOGICALP1101 (Ropeginterferon alfa-2b)

The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.