Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy - Full Text View

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