Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: P1101 (Ropeginterferon alfa-2b).
- Who it may be relevant to
- Registry conditions: Polycythemia Vera (PV). Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Detailed description
The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.
Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.
Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.
Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.
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.
Primary outcome measures
- Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks [Time frame: Through study completion, an average of 2 year]
Secondary outcome measures (8)
- Changes in hematocrit every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
- Changes in white blood cell every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
- Changes in platelet count every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
- Changes in red blood cell count every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
- Changes in spleen size every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
- Necessity of phlebotomy [Time frame: Through study completion, an average of 2 year]
- Proportion of subjects without thrombotic or hemorrhagic events [Time frame: Through study completion, an average of 2 year]
- Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time [Time frame: Through study completion, an average of 2 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 6 centers
- Ehime University Hospital — Toon-shi
- Mie University Hospital — Tsu
- Osaka University Hospital — Suita-shi
- Juntendo University Hospital — Bunkyo-ku
- Tokyo Medical University Hospital — Shinjuku-ku
- University of Yamanashi Hospital — Chuo-shi
Identifiers
NCT: NCT04655092 · A20-201