A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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Because patients with beta-thalassemia are unable to actively eliminate iron from the body, toxic and eventually lethal levels of iron can accumulate as a result of repeated blood transfusions. This study will evaluate the efficacy, safety and tolerability of deferasirox.

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Detailed Description

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Conditions

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Beta-Thalassemia Hemosiderosis

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

Group Type EXPERIMENTAL

deferasirox

Intervention Type DRUG

Interventions

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deferasirox

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Beta-thalassemia outpatients with transfusional hemosiderosis and unable to be chelated with deferoxamine (DFO) due to DFO being contra-indicated and/or due to documented unacceptable toxicity of DFO or documented poor response to DFO despite proper compliance, or documented non-compliance to DFO, with serum ferritin ≥ 500 ng/ml and LIC ≥ 2 mg/Fe/g dw liver
* Beta-thalassemia outpatients with transfusional hemosiderosis treated with deferiprone

Exclusion Criteria

* Means levels of ALT \> 300 U/L
* Serum creatinine above upper limit of normal
* Active hepatitis C or chronic hepatitis B receiving specific treatment

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No