Polycythemia Vera Myeloproliferative Neoplasms
Conditions
Interventions
This drug should be administered within 48 hours after the phlebotomy. In addition, as a dose escalation design, 4 doses of 0.25 mg/kg, 0.4 mg/kg, 0.64 mg/kg, and 1 mg/kg are administered to the same
Sponsors
Ito Tomoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria 2. PV patients being only treated with phlebotomy and the interval is 4-9 weeks
Exclusion criteria
Exclusion criteria: Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study (vital signs, Evaluation of laboratory test values, Standard 12-lead ECG, physical findings) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Measuring the concentration of PPMX-T003, calculate and assess each PK parameter Immunogenicity: Examining the expression rate and antibody titer of anti-drug antibodies (ADA) Pharmacodynamics: Assessment of the Red blood cell count, hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, total iron binding capacity, transferrin saturation | — |
Contacts
Public ContactTadashi Matsuura
Perseus Proteomics Inc.
Outcome results
None listed