Status:
COMPLETED
Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients
Lead Sponsor:
Lipomed
Conditions:
Hemochromatosis
Eligibility:
All Genders
4+ years
Phase:
PHASE2
Brief Summary
Systematical (retro- and prospective) investigation of the long-term safety (toxicity assessment according to CTCAE v3.0) and efficacy of deferiprone either given alone or in combination with desferri...
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, e.g. to the heart, liver and...
Eligibility Criteria
Inclusion
- Iron overloaded male or female patients with primary or secondary hemochromatosis
- Age: 4 years and older
- Patients with desferrioxamine toxicity or allergy (e.g. visual or hearing defects, bone abnormalities, reactions at injection site)
- Patients unable or unwilling to comply satisfactorily with regular desferrioxamine administration on 5-7 days/week
- Combination treatment: patients not sufficiently chelated with desferrioxamine or deferiprone monotherapy
- Patients must be willing to undergo routine screening including medical history, physical examination and hematology, biochemistry and other laboratory tests
- Written informed consent
Exclusion
- Children under 4 years of age
- Female and male of reproductive age, sexually active but not taking adequate contraceptive precaution
- Woman who are pregnant or breast-feeding
- Patients with HIV
- Patients with active hepatitis requiring treatment
- Patients with severe hepatic failure, cirrhosis
- Patients with neutropenia (neutrophils less than 1.5 exp9/l, MDS: less than 0.5 exp9/l)
- Patients with thrombocytopenia (platelets less than 100 exp9/l, MDS: less than 20 exp9/l)
- Patients with decompensated heart failure (LVEF less than 40% or patients under continuous cardiac medication)
- Patients with severe renal failure
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00349453
Start Date
March 1 2005
End Date
May 1 2011
Last Update
December 12 2011
Active Locations (13)
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1
Cantonal Hospital, Children's Clinic
Aarau, Canton of Aargau, Switzerland, 5001
2
Cantonal Hospital
Aarau, Canton of Aargau, Switzerland, 5001
3
Private children's practice
Bern, Canton of Bern, Switzerland, 3014
4
Children's Hospital of Eastern Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland, 9006