Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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 desferrioxamine

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lipomed
• Treatments: Deferiprone; Deferoxamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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