Status:
UNKNOWN
Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients
Lead Sponsor:
Sanquin Research & Blood Bank Divisions
Collaborating Sponsors:
Maastricht University Medical Center
Atrium Medical Center
Conditions:
Hereditary Hemochromatosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytaphere...
Detailed Description
The research population exists of patients with HH ( by genetic analysis confirmed as homozygous for C282Y) living in south-east of the Netherlands and currently treated with phlebotomy as maintenance...
Eligibility Criteria
Inclusion
- homozygous for C282Y
- currently treated with phlebotomy as maintenance therapy for at least 6 month
- ferritin level between 30-50 micog/L
- age 18 years an older
- weight more than 50 kg
- signed informed consent
- willingness to fill out additional questionnaires at three points in time
Exclusion
- chelating therapy
- forced dietary regime
- aged below 18 years
- excessive overweight ( BMI more than 35)
- pregnancy
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01398644
Start Date
May 1 2008
End Date
December 1 2013
Last Update
December 4 2013
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands, 6300