drugset / Trial / NCT00940602

Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study

NCT00940602 ↗

Phase 2 Completed 225 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.

Timeline

Start
2010-03-22
Primary completion
2018-02-27
Completion
2018-02-27

Outcome

Met primary endpoint

registry analysis (other test); Deferasirox vs Placebo; p = 0.015; Hazard Ratio (HR) 0.636 (95% CI 0.42 to 0.96) NCT00940602 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 20 mg/kg Oral