drugset / Trial / NCT01948817

Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses

NCT01948817

Phase 2 Withdrawn Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, single arm, and multicenter study. The study will include the following phases. A screening phase which lasts for 4 weeks to determine patient eligibility. This phase will be followed by a 24 week Open label treatment phase. The study treatment is defined as deferasirox 20mg/kg BID 9Twice a day). Serum Ferritin Levels and MRI (Magmetic Resonance Imaging) LIC (Liver Iron Concentration) will be measured to evaluate the response to BID.

Timeline

Start
2014-02
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 20 mg/kg

Indications

No indication recorded.