Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

Last updated: December 3, 2013
Sponsor: Sanquin Research & Blood Bank Divisions
Overall Status: Trial Status Unknown

Phase

3

Condition

Anemia

Iron Overload (Hemachromatosis)

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01398644
07-2-104
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • chelating therapy

  • forced dietary regime

  • aged below 18 years

  • excessive overweight ( BMI more than 35)

  • pregnancy

Study Design

Total Participants: 40
Study Start date:
May 01, 2008
Estimated Completion Date:
December 31, 2013

Study 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 treatment to keep their serum ferritin levels < 50 ug/l. Ferritin level at start of the inclusion between 30-50ug/l. Exclusion criteria are: patient receiving other therapies such as chelating therapy or forced dietary regimen, further patients with excessive overweight (BMI>35). After enrollment the patients will be randomized to start either with TE or continue with P. After a year of treatment and being at a serum ferritin level <50ug/l, patients will continue the study but then being treated with the other of the two treatments. Randomization will be done by blocked randomization.

Connect with a study center

  • University Hospital Maastricht

    Maastricht, 6300
    Netherlands

    Site Not Available

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