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Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
This study has been completed.
Study NCT00202436   Information provided by Sanquin Research & Blood Bank Divisions
First Received: September 13, 2005   Last Updated: October 19, 2009   History of Changes

September 13, 2005
October 19, 2009
October 2004
December 2008   (final data collection date for primary outcome measure)
Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ] [ Designated as safety issue: Yes ]
frritine
Complete list of historical versions of study NCT00202436 on ClinicalTrials.gov Archive Site
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ] [ Designated as safety issue: No ]
Same as current
 
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Hemochromatosis
  • Procedure: Phlebotomy
  • Procedure: Erythrocytapheresis
  • Active Comparator: Phlebotomy
  • Active Comparator: Erythrocytapheresis
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
September 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hereditary haemochromatosis patients

Exclusion Criteria:

  • Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00202436
Dr.Wim de Kort PhD, Sanquin Blood Bank South-east
PPO-C- 03-006
Sanquin Research & Blood Bank Divisions
  • Maastricht University Medical Center
  • Atrium Medical Center
  • Radboud University
Principal Investigator: Eva Rombout, MD Sanquin Research and Blood Bank Divisions
Sanquin Research & Blood Bank Divisions
October 2009

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