Clinical trial: Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients (NCT00349453)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.


Patient description (medical language): A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug.  Blood pressure is 120/80 mm Hg and pulse is 70/min.  Oxygen saturation is 99% on room air.  BMI is 24 kg/m2.  Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis.

Patient description (patient's own words): I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550  μg/L. The doctor diagnosed me with iron overload.

Does the patient match the trial criteria? Contradiction