Conditions: Liver Iron Overload
Keywords: iron overload iron chelation therapy B-thalassemia
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.

Detailed description:

Arms:
arm 1: Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study arm 2: Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5mg/kg/day to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study

Interventions: intervention 1: Deferasirox intervention 2: Deferasirox
Intervention descriptions: intervention 1: 10 mg/kg or 30 mg/kg orally daily intervention 2: 5 mg/kg or 30 mg/kg orally daily

Protocol document: