Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy - Tabular View

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Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

This study is currently recruiting participants.

Study NCT00202436. Last updated on February 26, 2007. Information provided by Sanquin Research & Blood Bank Divisions

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Official Title ^†

Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

frritine

Secondary Outcome Measure ^†

Condition ^†

Hemochromatosis

Intervention ^†

Procedure: Phlebotomy, erythrocytapheresis

MEDLINE PMIDs

Links

Related Info This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

October 2004

Completion Date

September 2006

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Eva Rombout

0031433871456

e.rombot@sanquin.nl

Location Countries ^†

Netherlands

Administrative Information Fields

NCT ID ^†

NCT00202436

Organization ID

PPO-C- 03-006

Secondary IDs ^††

Study Sponsor ^†

Sanquin Research & Blood Bank Divisions

Collaborators ^††

Maastricht University Medical Center
Atrium Medical Center
Radboud University

Investigators ^†

Principal Investigator:

Eva Rombout, MD

Sanquin Research and Blood Bank Divisions

Information Provided By

Sanquin Research & Blood Bank Divisions

Verification Date

February 2007

First Received Date ^†

September 13, 2005

Last Updated Date

February 26, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.