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Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Hereditary Hemochromatosis Clinical Trial

Official title:
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

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

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00440986
Study type Interventional
Source San Filippo Neri General Hospital
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2003
Completion date December 2006
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See also
  Status Clinical Trial Phase
Completed NCT03395704 - A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis Phase 2
Unknown status NCT01398644 - Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients Phase 3
Terminated NCT05238207 - A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers Phase 1
Completed NCT04202965 - PTG-300 in Subjects With Hereditary Hemochromatosis Phase 2
Enrolling by invitation NCT05742035 - Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin. N/A
Completed NCT03203850 - Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH) Phase 2
Completed NCT00068159 - Cardiac Function in Patients With Hereditary Hemochromatosis
Completed NCT00395629 - Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis Phase 1/Phase 2