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Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

This study has been completed.
Sponsor:
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT00440986
First received: February 26, 2007
Last updated: February 28, 2007
Last verified: February 2007
History of Changes
  Purpose

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
Hereditary Hemochromatosis
 Procedure: Eritrocytoapheresis
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Resource links provided by NLM:

MedlinePlus related topics: Hemochromatosis
U.S. FDA Resources

Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:
  • To prospectively determine the best choice of tretment in HH
  • To evaluate the global outcome according to treatment choice

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

Estimated Enrollment: 25
Study Start Date: April 2003
Estimated Study Completion Date: December 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Additional 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
Study First Received: February 26, 2007
Last Updated: February 28, 2007
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013