Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lipomed
• Treatments: Deferiprone; Deferoxamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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