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Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

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ClinicalTrials.gov Identifier: NCT00440986
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : March 1, 2007
Sponsor:
Information provided by:
San Filippo Neri General Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hereditary Hemochromatosis Procedure: Eritrocytoapheresis Phase 2 Phase 3

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Study Start Date : April 2003
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To prospectively determine the best choice of tretment in HH
  2. To evaluate the global outcome according to treatment choice

Secondary Outcome Measures :
  1. To evaluate the outcome of specific clinical features according to treatment choice

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patiens newly diagnosed having Hereditary Hemochromatosis

Exclusion Criteria:

  • Age < 18 yrs.
  • Not obese (BMI <30)
  • Not consuming alchol beverages,
  • Not affected by systemic diseases and known hepatic viruses
Contacts and Locations
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Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440986


Locations
Italy
Department of Transfusion Medicine-San Filippo Neri General Hospital
Rome, Italy, 00135
Sponsors and Collaborators
San Filippo Neri General Hospital
Investigators
Principal Investigator: Francesco Equitani, M.D. San Filippo Neri General Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00440986     History of Changes
Other Study ID Numbers: CMHHPE
HH1
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by San Filippo Neri General Hospital:
Clinical Management
Phlebotomy
Eritrocytoapheresis

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Iron Overload
Iron Metabolism Disorders
Metabolic Diseases