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Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

This study is currently recruiting participants.
Verified by Sanquin Research & Blood Bank Divisions, February 2007

Sponsors and Collaborators: Sanquin Research & Blood Bank Divisions
Maastricht University
Atrium Medical Center
Radboud University
Information provided by: Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier: NCT00202436
  Purpose

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.


Condition Intervention Phase
Hemochromatosis
Procedure: Phlebotomy, erythrocytapheresis
Phase III

Genetics Home Reference related topics:   hemochromatosis   

MedlinePlus related topics:   Hemochromatosis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:   Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • frritine

Estimated Enrollment:   40
Study Start Date:   October 2004
Estimated Study Completion Date:   September 2006

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202436

Contacts
Contact: Eva Rombout     0031433871456     e.rombot@sanquin.nl    

Locations
Netherlands
Sanquin Blood Bank Southeast Region     Recruiting
      Maastricht, Netherlands, 6229 GR
      Contact: Eva Rombout, MD         e.rombout@sanquin.nl    
      Principal Investigator: Eva Rombout, MD            

Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Maastricht University
Atrium Medical Center
Radboud University

Investigators
Principal Investigator:     Eva Rombout, MD     Sanquin Research and Blood Bank Divisions    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   PPO-C- 03-006
First Received:   September 13, 2005
Last Updated:   February 26, 2007
ClinicalTrials.gov Identifier:   NCT00202436
Health Authority:   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:
Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Hemochromatosis, type 3
Hemochromatosis
Iron Metabolism Disorders
Iron Overload
Metabolic disorder

Additional relevant MeSH terms:
Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 05, 2008




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