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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
Information provided by:

February 26, 2007
February 27, 2007
March 1, 2007
April 2003
Not Provided
  • To prospectively determine the best choice of tretment in HH
  • To evaluate the global outcome according to treatment choice
Same as current
Complete list of historical versions of study NCT00440986 on ClinicalTrials.gov Archive Site
To evaluate the outcome of specific clinical features according to treatment choice
Same as current
Not Provided
Not Provided
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
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
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
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hereditary Hemochromatosis
Procedure: Eritrocytoapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
San Filippo Neri General Hospital
Not Provided
Principal Investigator: Francesco Equitani, M.D. San Filippo Neri General Hospital
San Filippo Neri General Hospital
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP