Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox; Deferoxamine; Iron

Criteria

Inclusion Criteria:

• Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.

• Patients currently participating in the food-effect sub-study, according to amendment 3.

• Ability to provide written informed consent prior to participation in this non-comparative extension study.

• Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.

• Body weight of at least 35 kg.

Exclusion Criteria:

• Pregnant or breastfeeding patients.

• History of non-compliance to medical regimens and patients who are considered potentially unreliable.

• Proteinuria > 300 mg/L second void morning urine.

• Patients with serum creatinine above the upper limit normal.

Other protocol-defined inclusion/exclusion criteria may apply.