Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

San Filippo Neri General Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hereditary Hemochromatosis

Treatments: Procedure: Eritrocytoapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT00440986

HH1

CMHHPE

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)