This is an extension study after completion of Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.
Name: P1101 (Rropeginterferon alfa-2b)
Description: 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
Measure: Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in hematocrit every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in white blood cell every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in platelet count every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in red blood cell count every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in spleen size every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Necessity of phlebotomy Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Proportion of subjects without thrombotic or hemorrhagic events Time: Through study completion, an average of 2 yearDescription: Baseline is defined as Week 52 in Study A19-201
Measure: Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time Time: Through study completion, an average of 2 yearDescription: 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
Measure: Bone marrow histological remission (optional) Time: Through study completion, an average of 2 yearAllocation: N/A
Single Group Assignment
There is one SNP
Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time. --- V617F ---