Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 19, 2009

Start Date ^ICMJE

October 2004

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

frritine

Change History

Complete list of historical versions of study NCT00202436 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hemochromatosis

Intervention ^ICMJE

Procedure: Phlebotomy
Procedure: Erythrocytapheresis

Study Arms / Comparison Groups

Active Comparator: Phlebotomy
Active Comparator: Erythrocytapheresis

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00202436

Responsible Party

Dr.Wim de Kort PhD, Sanquin Blood Bank South-east

Study ID Numbers ^ICMJE

PPO-C- 03-006

Study Sponsor ^ICMJE

Sanquin Research & Blood Bank Divisions

Collaborators ^ICMJE

Maastricht University Medical Center
Atrium Medical Center
Radboud University

Investigators ^ICMJE

Principal Investigator:

Eva Rombout, MD

Sanquin Research and Blood Bank Divisions

Information Provided By

Sanquin Research & Blood Bank Divisions

Verification Date

October 2009

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