Conditions: Aplastic Anemia
Keywords: Aplastic anemia deferasirox ICL670 renal function transfusion-dependent iron overload immunosuppressive treatment Cyclosporine A unosuppressive treatment without chelation therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.

Detailed description:
The secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.

Arms:
arm 1: Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study arm 2: Transfusion-dependent adult patients with AA and serum ferritin \< 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product

Interventions: intervention 1: ICL670 intervention 2: Chelation intervention 3: No chelation
Intervention descriptions: intervention 1: ICL670 was supplied in registered packages as 250mg or 500mg dispersible tablets. intervention 2: Main group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment (immunosupressant - Cyclosporine A) and received chelation with ICL670 (deferasirox). intervention 3: Comparative group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment ( immunosupressant -Cyclosporine A)

Protocol document: