Status:
COMPLETED
A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis
Lead Sponsor:
Novartis
Conditions:
Beta-Thalassemia
Hemosiderosis
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- Means levels of ALT \> 300 U/L
- Serum creatinine above upper limit of normal
- Active hepatitis C or chronic hepatitis B receiving specific treatment
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00171171
Start Date
May 1 2004
Last Update
March 1 2017
Active Locations (5)
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1
Novartis Investigative Site
Cairo, Egypt
2
Ali Taher
Beirut, Lebanon, Riad El Solh 1107 2020
3
Novartis Investigative Site
Muscat, Oman
4
Novartis Investigative Site
Riyadh, Saudi Arabia