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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1101 (Ropeginterferon alfa-2b) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P1101 (Ropeginterferon alfa-2b) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks | CHR will be defined as follows.
| Through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hematocrit every 52 weeks over time | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Changes in white blood cell every 52 weeks over time |
| Measure | Description | Time Frame |
|---|---|---|
| Bone marrow histological remission (optional) | Bone marrow histological remission was defined as the disappearance of hypercellularity and trilineage growth (panmyelosis), and absence of >grade 1 reticulin fibrosis in the subjects who gave informed consent in Study A19-201 | Through study completion, an average of 2 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroaki Kawase | Contact | +81-3-6910-5103 | hiroaki_kawase@pharmaessentia.com |
| Name | Affiliation | Role |
|---|---|---|
| Keita Kirito, MD | University of Yamanashi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehime University Hospital | Recruiting | Toon-shi | Ehime | 791-0295 | Japan | |
| Mie University Hospital |
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| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Conventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of P1101 (ropeginterferon alfa-2b) once every 2 weeks
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|
Baseline is defined as Week 52 in Study A19-201
| Through study completion, an average of 2 year |
| Changes in platelet count every 52 weeks over time | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Changes in red blood cell count every 52 weeks over time | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Changes in spleen size every 52 weeks over time | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Necessity of phlebotomy | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Proportion of subjects without thrombotic or hemorrhagic events | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time | Baseline is defined as Week 52 in Study A19-201 | Through study completion, an average of 2 year |
| Recruiting |
| Tsu |
| Mie-ken |
| Japan |
| Osaka University Hospital | Recruiting | Suita-shi | Osaka | 565-0871 | Japan |
| Juntendo University Hospital | Recruiting | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Medical University Hospital | Recruiting | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| University of Yamanashi Hospital | Recruiting | Chuo-shi | Yamanashi | 409-3898 | Japan |
| D001855 |
| Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |