Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Hereditary Hemochromatosis Clinical Trial

Official title:

Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440986
• Other study ID #: CMHHPE
• Secondary ID: HH1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 26, 2007
• Last updated: February 28, 2007
• Start date: April 2003
• Est. completion date: December 2006

Study information

• Verified date: February 2007
• Source: San Filippo Neri General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemochromatosis
• Hereditary Hemochromatosis

Intervention

Procedure:
• Eritrocytoapheresis

Locations

Country	Name	City	State
Italy	Department of Transfusion Medicine-San Filippo Neri General Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prospectively determine the best choice of tretment in HH
Primary	To evaluate the global outcome according to treatment choice
Secondary	To evaluate the outcome of specific clinical features according to treatment choice