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.
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
Single group
P1101 (Ropeginterferon alfa-2b)
Biological/VaccineThe 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.
Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks
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
Changes in hematocrit every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Changes in white blood cell every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Changes in platelet count every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
Changes in red blood cell count every 52 weeks over time
Baseline is defined as Week 52 in Study A19-201
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
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