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

Overview

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.

Full Title of Study: “Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Patients With Hereditary Hemochromatosis; a Randomised, Single Blinded Sequential, Cross-over Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2013

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 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.

Interventions

  • Other: Phlebotomy and erythrocytapheresis
    • Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

Arms, Groups and Cohorts

  • Active Comparator: Phlebotomy -intervention phlebotomy
    • Patients are treated with phlebotomy if ferritin level >50 ug/l
  • Experimental: Erythrocytapheresis
    • Patients are treated with erythrocytapheresis if serum ferritin level >50ug/l

Clinical Trial Outcome Measures

Primary Measures

  • The difference in number of required treatments and the interval between treatments per year to keep the serum ferritin levels between 30-50 microg/L
    • Time Frame: one year after first phlebotomy treatment and one year after first erythrocytapheresis treatment

Participating in This Clinical Trial

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 Criteria

  • chelating therapy
  • forced dietary regime
  • aged below 18 years
  • excessive overweight ( BMI more than 35)
  • pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sanquin Research & Blood Bank Divisions
  • Collaborator
    • Maastricht University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eva Rombout, Transfusion specialist – Sanquin Research & Blood Bank Divisions
  • Overall Official(s)
    • Eva Rombout, MD, Principal Investigator, Sanquin Blood Supply

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.