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

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ClinicalTrials.gov Identifier: NCT01398644
Recruitment Status : Unknown
Verified December 2013 by Eva Rombout, Sanquin Research & Blood Bank Divisions.
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : December 4, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Hereditary Hemochromatosis Other: Phlebotomy and erythrocytapheresis Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : May 2008
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Eva Rombout, 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