Ironacumulation Ironoverload
Conditions
Interventions
TE as a new therapeutic modality to reduce and/or prevent iron overload during
maintenance therapy. This method will be compared with P, which is the current
standard maintenance therapy. TE allows
Sponsors
Sanquin Bloedbank
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with ironoverload, homozygous for C282Y, treated with Phlebotomy as maintenance therapy for at least 6 month Demonstrated therapy compliance with prescribed P so far Ferritin level between 30-50 ug/L at start of the inclusion Age 18 years an older Weight > 50 kg Signed informed consent Willigness to fill out additional questionnaires at three points in time
Exclusion criteria
Exclusion criteria: Patients recieving others therapies such as chelating therapy or forced dietary regimen Patients younger than 18 years Patients with excessive overweight ( BMI>35) Patients which are mentally incapacitade Women being pregnant or expecting/planning to become pregnant during the two years period of the study Patients with a malignancy HH patients which are current blood donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The difference in number of required treatments and the interval between treatments per year to keep the serum ferritine levels between 30 - 50 µg/L. | — |
Secondary
| Measure | Time frame |
|---|---|
| The potential preference of the patients for one of the techniques. To obtain the answer to this secondary question, the patients are asked to fill in validated questionares (SF 36, EQSD, NRS BASDAI) | — |
Countries
Netherlands
Outcome results
None listed