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Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
Sponsor: PharmaEssentia Japan K.K.
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.
Official title: 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)
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2021-01-19
Completion Date
2026-06-30
Last Updated
2024-11-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
Ehime University Hospital
Toon-shi, Ehime, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan