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

This study is currently recruiting participants.
Verified July 2011 by Sanquin Research & Blood Bank Divisions
Sponsor:
Collaborators:
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Orbis Medical Centre
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT01398644
First received: July 19, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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
 Procedure: Phlebotomy and therapeutic 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:

MedlinePlus related topics: Hemochromatosis Iron
U.S. FDA Resources

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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phlebotomy and therapeutic erythrocytapheresis Procedure: Phlebotomy and therapeutic erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of erythrocytes
Other Names:
  • Bloodleting
  • erythrocytapheresis

  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

Contacts
Contact: Eva Rombout-Sestrienkova, MD 0031 6 20616541 e.rombout@sanquin.nl

Locations
Netherlands
University Hospital Maastricht Recruiting
Maastricht, Netherlands, 6300
Contact: Ger H Koek     0031 43 3876543     ghkoek@mumc.nl    
Principal Investigator: Ger Koek, MD PhD            
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Orbis Medical Centre
  More Information

No publications provided

Responsible Party: Eva Rombout-Sestrienkova, Sanquin Research & Blood Bank Divisions and Univeristy Hospital Maastricht (MUMC
ClinicalTrials.gov Identifier: NCT01398644     History of Changes
Other Study ID Numbers: 07-2-104
Study First Received: July 19, 2011
Last Updated: July 19, 2011
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 June 17, 2013