Long-term Observation of the Effects of T003

A Study to Explore Trends in Pathological Changes Based on Pharmacodynamic Effects of T003 and Changes in Laboratory Test Values in Participants of the PPMX-T003-CT102 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1050250129

Enrollment

Registered

2025-10-14

Start date

2025-10-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera Myeloproliferative Neoplasms

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Participants who were enrolled as eligible cases in the PPMX-T003-CT102 trial and received administration of T003

Exclusion criteria

Exclusion criteria: Individuals deemed unsuitable as research subjects by the principal investigator or co-investigator

Design outcomes

Primary

Measure	Time frame
Estimation of Pharmacodynamic Effects of T003: Based on the time-series changes in clinical laboratory values (red blood cell count, hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, total iron-binding capacity, transferrin saturation, white blood cell count (including differential count), platelet count, erythropoietin) over time, treatment history including phlebotomy, medical history, and changes in the JAK2 V617F mutation rate. Descriptive summaries and analyses of changes in disease status from before to during and after participation in the PPMX-T003-CT102 trial will be conducted.	—

Measure

Time frame

Estimation of Pharmacodynamic Effects of T003: Based on the time-series changes in clinical laboratory values (red blood cell count, hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, total iron-binding capacity, transferrin saturation, white blood cell count (including differential count), platelet count, erythropoietin) over time, treatment history including phlebotomy, medical history, and changes in the JAK2 V617F mutation rate. Descriptive summaries and analyses of changes in disease status from before to during and after participation in the PPMX-T003-CT102 trial will be conducted.

—

Contacts

Public ContactTomoki Ito

Kansai Medical University Hospital

ito.tom@kmu.ac.jp+81-72-804-0101

Outcome results