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Sponsors and Collaborators: |
University of Bergen Helse Fonna Haukeland University Hospital University Hospital, Akershus |
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Information provided by: | University of Bergen |
ClinicalTrials.gov Identifier: | NCT00509652 |
Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The condition may result in serious organ damage which can be prevented by therapy, but only few patients develop such organ damage. The optimal treatment, therefore, is still a matter of discussion Prevention of organ damage has traditionally been accomplished by drawing of full blood (phlebotomy), which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment. The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective removal of red blood cells (red cell apheresis). Possible drawbacks of this technique may be higher costs, prolonged time for each therapeutic procedure, and certain requirements to the patients. The possible advantages are the reduced number of therapeutic procedures and less strain for the patient. No larger, randomized study has been published in order to determine which method should be preferred.
This study is a controlled trial in which participating patients are asked to be randomized to red cell apheresis or traditional phlebotomy. Each group will be followed by means of well-defined assessments in order to explore possible advantages and disadvantages of each method in order to establish what type of treatment should be recommended.
Condition | Intervention |
---|---|
Hemochromatosis |
Procedure: Arm 1: Erythrocyte apheresis Procedure: Arm 2: Whole blood phlebotomy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Therapeutic Effect of Erythrocyte Apheresis as Compared to Full Blood Phlebotomy in Patients With Hereditary Hemochromatosis |
Estimated Enrollment: | 67 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
Erythrocyte apheresis
|
Procedure: Arm 1: Erythrocyte apheresis
Erythrocyte apheresis
|
Arm 2: Active Comparator
Phlebotomy
|
Procedure: Arm 2: Whole blood phlebotomy
Traditional whole blood phlebotomy
|
Introduction Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The condition may result in serious organ damage which can be prevented by therapy, but only few patients develop such organ damage. Provided the lack of more exact knowledge of which patients should be treated, we have based our inclusion criteria on the guidelines published by the Norwegian Society of Hematology. However, the criteria for ferritin levels have been set at 300 micrograms/L for patients who are homozygous for the C282Y mutation, and also heterozygous individuals will be included if ferritin is higher than 500 micrograms/L.
Furthermore, the optimal treatment method is still a matter of discussion. Prevention of organ damage has traditionally been accomplished by whole blood phlebotomy, which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment. The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective withdrawal of red blood cells (erythrocyte apheresis). Possible drawbacks of this technique may be higher costs, prolonged time for each therapeutic procedure, and certain requirements to the patients. The possible advantages are the reduced number of therapeutic procedures and less strain for the patient. No larger, randomized study has been published in order to determine which method should be preferred.
Hypothesis: A more rapid decline of primary endpoints (see below) can be achieved by erythrocyte apheresis as compared to traditional phlebotomy, without significant disadvantages.
Design The trial is prospective, randomized and open. Eligible patients are randomized to erythrocyte apheresis and phlebotomy.
Endpoints Primary endpoints Decline of ferritin levels and transferrin saturation.
Secondary endpoints and other variables to be studied Decline in hemoglobin levels. Discomfort during the therapeutic procedure. Any changes in EVF, blood cell counts or albumin and CRP levels. Certain well-defined financial costs: consumed material, technician working time.
Inclusion criteria
Diagnosis
Treatment schedule Following randomization to either apheresis or phlebotomy, patients are treated until ferritin levels have declined to below 50 micrograms/L and they are then followed for one year. Patients randomized to apheresis are treated every second week, whereas patients in the phlebotomy group are treated weekly. Prolongation of the interval is permitted in both groups in case of well-defined clinical indications. Any prolongation is to be recorded along with the clinical indication.
Follow-up Clinical symptoms, body weight, laboratory findings (Hemoglobin levels; blood cell counts; levels of iron, transferrin, ferritin, albumin and IgG; serologic assessments for hepatitis viruses, CMV and HIV), discomfort during the therapeutic procedure, duration of each procedure, costs for consumed material, working time of the technician for each procedure.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis
Exclusion Criteria:
Contact: Tatjana Sundic, MD | +47-52732000 | tatjana.sundic@helse-fonna.no |
Contact: Sigbjorn Berentsen, MD, PhD | +47-52732000 | s.beren@online.no |
Norway | |
Haugesund Hospital, Department of Immunology and Transfusion Medicine | Recruiting |
Haugesund, Norway, N-5504 | |
Contact: Tatjana Sundic, MD +47-52732000 tatjana.sundic@helse-fonna.no | |
Contact: Sigbjorn Berentsen, MD, PhD +47-52732000 s.beren@online.no | |
Haukeland University Hospital, Department of Transfusion Medicine | Recruiting |
Bergen, Norway, N-5021 | |
Contact: Tor Hervig, MD, PhD +47-55975000 tor.hervig@helse-bergen.no | |
Contact: Signe Hannisdahl +47-55975000 signe@hannisdahl@helse-bergen.no | |
Akershus University Hospital (AHUS), Department of Transfusion Medicine | Recruiting |
Nordbyhagen, Norway, N-1474 | |
Contact: Richard W Olaussen, MD +47-67928800 richard.olaussen@ahus.no |
Principal Investigator: | Tatjana Sundic, MD | Department of Immunology and Transfusion Medicine, Haugesund Hospital |
Study Chair: | Sigbjorn Berentsen, MD, PhD | Department of Medicine, Haugesund Hospital |
Study Chair: | Tor Hervig, MD, PhD | Department of Transfusion Medicine, Haukeland University Hospital |
Study ID Numbers: | NSD13903 |
Study First Received: | July 27, 2007 |
Last Updated: | July 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00509652 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
Hemochromatosis Primary hemochromatosis Hereditary hemochromatosis Therapy |
Erythrocyte apheresis Phlebotomy Apheresis Efficacy |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Hemochromatosis, type 3 |
Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic disorder |
Metal Metabolism, Inborn Errors |