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:

Genetics Home Reference related topics: hemochromatosis

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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

Additional 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
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 Genetic Diseases, Inborn Iron Metabolism Disorders Iron Overload	Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on March 02, 2015

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