Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

This study has been completed.
Sponsor:
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT00440986
First received: February 26, 2007
Last updated: February 28, 2007
Last verified: February 2007
  Purpose

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


Condition Intervention Phase
Hereditary Hemochromatosis
Procedure: Eritrocytoapheresis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Resource links provided by NLM:


Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:
  • To prospectively determine the best choice of tretment in HH
  • To evaluate the global outcome according to treatment choice

Secondary Outcome Measures:
  • To evaluate the outcome of specific clinical features according to treatment choice

Estimated Enrollment: 25
Study Start Date: April 2003
Estimated Study Completion Date: December 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440986

Locations
Italy
Department of Transfusion Medicine-San Filippo Neri General Hospital
Rome, Italy, 00135
Sponsors and Collaborators
San Filippo Neri General Hospital
Investigators
Principal Investigator: Francesco Equitani, M.D. San Filippo Neri General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00440986     History of Changes
Other Study ID Numbers: CMHHPE, HH1
Study First Received: February 26, 2007
Last Updated: February 28, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by San Filippo Neri General Hospital:
Clinical Management
Phlebotomy
Eritrocytoapheresis

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 10, 2014