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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

July 19, 2011
December 3, 2013
May 2008
December 2013   (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
Complete list of historical versions of study NCT01398644 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hereditary Hemochromatosis
Other: Phlebotomy and erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes
  • Active Comparator: Phlebotomy -intervention phlebotomy
    Patients are treated with phlebotomy if ferritin level >50 ug/l
    Intervention: Other: Phlebotomy and erythrocytapheresis
  • Experimental: Erythrocytapheresis
    Patients are treated with erythrocytapheresis if serum ferritin level >50ug/l
    Intervention: Other: Phlebotomy and erythrocytapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2013
December 2013   (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 information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01398644
07-2-104
No
Eva Rombout, Sanquin Research & Blood Bank Divisions
Sanquin Research & Blood Bank Divisions
  • Maastricht University Medical Center
  • Atrium Medical Center
  • Radboud University
  • Orbis Medical Centre
Principal Investigator: Eva Rombout, MD Sanquin Blood Supply
Sanquin Research & Blood Bank Divisions
December 2013

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