NCT00440986

Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: San Filippo Neri General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

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

Conditions

• Hereditary Hemochromatosis

Interventions

Type	Name	Description
PROCEDURE	Eritrocytoapheresis

Timeline

• Start date: 2003-04-01
• Completion: 2006-12-01
• First posted: 2007-02-27
• Last updated: 2007-03-01

Locations

1 site across 1 country: Italy