Overview

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