NCT01818726

Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients

Open-label Study of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients Undergoing Treatment Programs in Comparison With Control Group

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	ICL670	ICL670 was supplied in registered packages as 250mg or 500mg dispersible tablets.
DRUG	Chelation	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).
DRUG	No chelation	Comparative group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment ( immunosupressant -Cyclosporine A)

Timeline

• Start date: 2014-06-23
• Primary completion: 2016-10-17
• Completion: 2016-10-17
• First posted: 2013-03-26
• Last updated: 2019-08-16
• Results posted: 2019-08-16

Locations

1 site across 1 country: Russia