CompletedPhase 3

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

Egypt, Lebanon, Oman252 participantsStarted 2004-05

Plain-language summary

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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Liver Iron Concentration (as measured by biopsy)

Timeframe: at baseline and after 1 yeor of ICL670 treatment

Trial details

NCT IDNCT00171171

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-11

View on ClinicalTrials.gov More Beta-Thalassemia trials