Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Iron Overload

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deferasirox

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

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

10 mg/kg or 30 mg/kg orally daily

Deferasirox Crossover

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

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

5 mg/kg or 30 mg/kg orally daily

Interventions

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Deferasirox

10 mg/kg or 30 mg/kg orally daily

Intervention Type DRUG

Deferasirox

5 mg/kg or 30 mg/kg orally daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No