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Sponsored by: |
San Filippo Neri General Hospital |
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Information provided by: | San Filippo Neri General Hospital |
ClinicalTrials.gov Identifier: | NCT00440986 |
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH
Condition | Intervention | Phase |
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Hereditary Hemochromatosis |
Procedure: Eritrocytoapheresis |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis |
Estimated Enrollment: | 25 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | December 2006 |
Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Department of Transfusion Medicine-San Filippo Neri General Hospital | |
Rome, Italy, 00135 |
Principal Investigator: | Francesco Equitani, M.D. | San Filippo Neri General Hospital |
Study ID Numbers: | CMHHPE, HH1 |
Study First Received: | February 26, 2007 |
Last Updated: | February 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00440986 |
Health Authority: | Italy: Ministry of Health |
Clinical Management Phlebotomy Eritrocytoapheresis |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Hemochromatosis, type 3 |
Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic disorder |
Metal Metabolism, Inborn Errors |