drugset / Trial / NCT05853458

Evaluation of HU-resistance in Adult Patients With Polycythemia Vera Who Meet PV-AIM Predictors

NCT05853458

Phase 4 Terminated 76 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to confirm the predictive factors for hydroxyurea (HU) failure (hemoglobin (HGB) \<15.5 g/dL (9.62 mmol/L) and red blood cell distribution width (RDW) ≥17%) identified by machine learning in the polycythemia vera advanced integrated model (PV-AIM) project in the real-life setting.

Timeline

Start
2023-07-28
Primary completion
2026-02-26
Completion
2026-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified Oral