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

PHASE3RecruitingINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

January 19, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Polycythemia Vera (PV)
Interventions
BIOLOGICAL

P1101 (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.

Trial Locations (6)

791-0295

RECRUITING

Ehime University Hospital, Toon-shi

Unknown

RECRUITING

Mie University Hospital, Tsu

565-0871

RECRUITING

Osaka University Hospital, Suita-shi

113-8431

RECRUITING

Juntendo University Hospital, Bunkyo-ku

160-0023

RECRUITING

Tokyo Medical University Hospital, Shinjuku-ku

409-3898

RECRUITING

University of Yamanashi Hospital, Chuo-shi

Sponsors
All Listed Sponsors
lead

PharmaEssentia Japan K.K.

INDUSTRY