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NCT00202436 Clinical Trial

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

Hemochromatosis Clinical Trial

Official title:
Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00202436
Other study ID # PPO-C- 03-006
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated October 19, 2009
Start date October 2004
Est. completion date September 2009

Study information
Verified date October 2009
Source Sanquin Research & Blood Bank Divisions
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Phlebotomy
Removal of 500 ml whole blood
• Erythrocytapheresis
machinal removal of erythrocytes

Locations
Country Name City State
Netherlands Sanquin Blood Bank Southeast Region Maastricht

Sponsors (4)
Lead Sponsor Collaborator
Sanquin Research & Blood Bank Divisions Atrium Medical Center, Maastricht University Medical Center, Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment duration and number of treatments Ferritine value 50 microgr/l Yes
Secondary Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs Ferritine value 50microgr/l No
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Not yet recruiting NCT01524757 - Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis N/A
Completed NCT00349453 - Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients Phase 2
Recruiting NCT03743272 - Repeatability and Reproducibility of Multiparametric MRI
Recruiting NCT06137079 - "Iron Overload and Endocrinological Diseases"
Completed NCT00712738 - Oral Nifedipine to Treat Iron Overload Phase 1
Completed NCT00001455 - Iron Overload in African Americans N/A
Completed NCT00006312 - Hemochromatosis--Genetic Prevalence and Penetrance N/A
Completed NCT00005559 - Statistical Basis for Hemochromatosis Screening N/A
Recruiting NCT00509652 - Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis N/A
Completed NCT00350662 - Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients Phase 3
Completed NCT00005541 - Hemochromatosis and Iron Overload Screening Study (HEIRS) N/A
Completed NCT00000595 - Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis Phase 2
Completed NCT04631718 - MRI QSM Imaging for Iron Overload
Active, not recruiting NCT00007150 - Treatment of Hemochromatosis Phase 2
Completed NCT00587535 - Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration N/A
Enrolling by invitation NCT02025543 - Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

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