Clinical Trial: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
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
Detailed Summary: 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
Sponsor: San Filippo Neri General Hospital
Current Primary Outcome:
- To prospectively determine the best choice of tretment in HH
- To evaluate the global outcome according to treatment choice
Original Primary Outcome: Same as current
Current Secondary Outcome: To evaluate the outcome of specific clinical features according to treatment choice
Original Secondary Outcome: Same as current
Information By: San Filippo Neri General Hospital
Dates:
Date Received: February 26, 2007
Date Started: April 2003
Date Completion: December 2006
Last Updated: February 28, 2007
Last Verified: February 2007
