Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

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

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, Senior)
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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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:

Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. Review.

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

Equitani F, Fernandez-Real JM, Menichella G, Koch M, Calvani M, Nobili V, Mingrone G, Manco M. Bloodletting ameliorates insulin sensitivity and secretion in parallel to reducing liver iron in carriers of HFE gene mutations. Diabetes Care. 2008 Jan;31(1):3-8. Epub 2007 Oct 24.

ClinicalTrials.gov Identifier:	NCT00440986 History of Changes
Other Study ID Numbers:	CMHHPE; HH1
First Posted:	February 27, 2007
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