Patients with polycythemia vera (limited to cases where existing treatment is ineffective or inappro
Conditions
Interventions
None listed
Sponsors
PMS group R&D Div. PharmaEssentia Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Among patients with polycythemia vera (limited to cases where existing treatment is ineffective or inappropriate), 1. Patients who have agreed to participate in this study 2. Patients who have received Clozapine since the conclusion of the research agreement for this study.
Exclusion criteria
Exclusion criteria: Patients with contraindications to administration in BESREMi package insert.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety issues 1. Severity and frequency of adverse events and side effects (including unknown events) 2. Adverse events and adverse reactions by patient background factors 3. Adverse events and adverse reactions by major organ category, serious adverse events and adverse reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1. Haematological complete response rate (CHR), CHR rate over time, CHR persistence rate 2. Molecular genetic response (MR) rate 3. Absolute values (frequency) of haematocrit, white blood cell count, platelet count and phlebotomy frequency from baseline 4. Change from baseline in absolute values (frequency) of haematocrit values, white blood cell counts, platelet counts and phlebotomy frequency 5. Change from baseline in JAK2 V617F allele verden values | — |
Contacts
Public ContactPharmaEssentia Japan K.K. PMS Group
PharmaEssentia Japan K.K.
Outcome results
None listed