Status:
COMPLETED
Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients
Lead Sponsor:
Lipomed
Conditions:
Hemochromatosis
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief Summary
Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug
Detailed Description
Patients with refractory anemias requiring regular blood transfusions accumulate iron at the rate of approximately 0.5 mg/kg/day, which may lead to serious organ toxicity. The human body has no active...
Eligibility Criteria
Inclusion
- Iron-overloaded patients without prior iron chelation therapy as well as pretreated patients
- Age: 4 years and older
- Sex: male and female
- Written informed consent
Exclusion
- Children \< 4 years of age
- Patients non-compliant to DFO or L1
- Patients with known DFO or L1 toxicity/intolerance
- Neutropenia (neutrophils \< 1.5 x 10exp9/L)
- Thrombocytopenia (platelets \< 100 x 10exp9/L)
- Renal, hepatic (liver enzymes 2.5x of upper normal level and higher) or decompensated heart failure
- Active viral illness currently treated with interferon-alpha/ribavirin
- Patients with repeated Yersinia infections
- HIV-positivity
- Pregnancy and nursing
- Female and male of reproductive age planning for family, sexually active but not taking adequate contraceptive precaution
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00350662
Start Date
January 1 2002
Last Update
November 19 2012
Active Locations (2)
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1
Pediatric Hospital, Cairo University
Cairo, Egypt
2
EGE University Medical School
Bornova, Izmir, İzmir, Turkey (Türkiye), 35100