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)
Who is this study for? Adult Japanese patients with polycythemia vera for whom the current standard of treatment is difficult to apply
What treatments are being studied? P1101
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
University of Yamanashi Hospital
RECRUITING
Chuo-shi
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Osaka University Hospital
RECRUITING
Suita-shi
Ehime University Hospital
RECRUITING
Toon-shi
Mie University Hospital
RECRUITING
Tsu
Contact Information
Primary
Hiroaki Kawase
hiroaki_kawase@pharmaessentia.com
+81-3-6910-5103
Time Frame
Start Date: 2021-01-19
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 67
Treatments
Experimental: P1101 (Ropeginterferon alfa-2b)
Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.
Related Therapeutic Areas
Sponsors
Leads: PharmaEssentia Japan K.K.