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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

July 19, 2011
July 19, 2011
May 2008
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
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Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients
Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Patients With Hereditary Hemochromatosis; a Randomised, Single Blinded Sequential, Cross-over Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hereditary Hemochromatosis
Procedure: Phlebotomy and therapeutic erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of erythrocytes
Other Names:
  • Bloodleting
  • erythrocytapheresis
Phlebotomy and therapeutic erythrocytapheresis
Intervention: Procedure: Phlebotomy and therapeutic erythrocytapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
Contact: Eva Rombout-Sestrienkova, MD 0031 6 20616541 e.rombout@sanquin.nl
Netherlands
 
NCT01398644
07-2-104
No
Eva Rombout-Sestrienkova, Sanquin Research & Blood Bank Divisions and Univeristy Hospital Maastricht (MUMC
Sanquin Research & Blood Bank Divisions
  • Maastricht University Medical Center
  • Atrium Medical Center
  • Radboud University
  • Orbis Medical Centre
Not Provided
Sanquin Research & Blood Bank Divisions
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP