drugset / Trial / NCT01709838

Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia

NCT01709838

Phase 4 Completed 134 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.

Timeline

Start
2012-12-06
Primary completion
2015-01-03
Completion
2019-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg Oral

Indications