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Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

NCT ID: NCT00440986

Last Updated: 2007-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Hereditary Hemochromatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Eritrocytoapheresis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Filippo Neri General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Francesco Equitani, M.D.

Role: PRINCIPAL_INVESTIGATOR

San Filippo Neri General Hospital

Locations

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Department of Transfusion Medicine-San Filippo Neri General Hospital

Rome, , Italy

Site Status

Countries

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Italy

References

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Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. doi: 10.1056/NEJMra031573. No abstract available.

Reference Type BACKGROUND
PMID: 15175440 (View on PubMed)

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. doi: 10.2337/dc07-0939. Epub 2007 Oct 24.

Reference Type DERIVED
PMID: 17959863 (View on PubMed)

Other Identifiers

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HH1

Identifier Type: -

Identifier Source: secondary_id

CMHHPE

Identifier Type: -

Identifier Source: org_study_id

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