Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients
- Conditions
- Polycythemia Vera (PV)
- Interventions
- Biological: P1101 (Ropeginterferon alfa-2b)
- Registration Number
- NCT04655092
- Lead Sponsor
- PharmaEssentia Japan K.K.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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
- Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P1101 (Ropeginterferon alfa-2b) 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.
- Primary Outcome Measures
Name Time Method Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks Through study completion, an average of 2 year CHR will be defined as follows.
* Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks)
* Platelet count ≤ 400 x 10\^9/L
* WBC count ≤ 10 x 10\^9/L
- Secondary Outcome Measures
Name Time Method Changes in platelet count every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Changes in red blood cell count every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Changes in spleen size every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Changes in hematocrit every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Necessity of phlebotomy Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Changes in white blood cell every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Proportion of subjects without thrombotic or hemorrhagic events Through study completion, an average of 2 year Baseline is defined as Week 52 in Study A19-201
Trial Locations
- Locations (6)
Mie University Hospital
🇯🇵Tsu-shi, Mie, Japan
Ehime University Hospital
🇯🇵Toon-shi, Ehime, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
University of Yamanashi Hospital
🇯🇵Chuo-shi, Yamanashi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
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