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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Orbis Medical Centre
Information provided by (Responsible Party):
Eva Rombout, Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT01398644
First received: July 19, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hereditary Hemochromatosis
Other: Phlebotomy and erythrocytapheresis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Patients With Hereditary Hemochromatosis; a Randomised, Single Blinded Sequential, Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phlebotomy -intervention phlebotomy
Patients are treated with phlebotomy if ferritin level >50 ug/l
Other: Phlebotomy and erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes
Experimental: Erythrocytapheresis
Patients are treated with erythrocytapheresis if serum ferritin level >50ug/l
Other: Phlebotomy and erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398644

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6300
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Orbis Medical Centre
Investigators
Principal Investigator: Eva Rombout, MD Sanquin Blood Supply
  More Information

No publications provided

Responsible Party: Eva Rombout, Transfusion specialist, Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier: NCT01398644     History of Changes
Other Study ID Numbers: 07-2-104
Study First Received: July 19, 2011
Last Updated: December 3, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin Research & Blood Bank Divisions:
Phlebotomy
Therapeutic erythrocytapheresis
Hereditary Hemochromatosis
maintenance therapy

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014