Conditions: Chronic Iron Overload Due to Transfusion-dependant Anemias
Keywords: Iron overload Chelation Thalassemia Myelodysplastic syndrome (MDS) Transfusional hemisiderosis Deferasirox ICL670 Dispersible tablet Film-coated tablet
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 173
Healthy volunteers: no

Brief summary:
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

Detailed description:

Arms:
arm 1: Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose. arm 2: Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose

Interventions: intervention 1: Deferasirox dispersible tablet intervention 2: Defearisox film-coated tablet
Intervention descriptions: intervention 1: Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use. intervention 2: Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Protocol document: