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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

February 26, 2007
February 28, 2007
April 2003
Not Provided
  • To prospectively determine the best choice of tretment in HH
  • To evaluate the global outcome according to treatment choice
Same as current
Complete list of historical versions of study NCT00440986 on ClinicalTrials.gov Archive Site
To evaluate the outcome of specific clinical features according to treatment choice
Same as current
Not Provided
Not Provided
 
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hereditary Hemochromatosis
Procedure: Eritrocytoapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2006
Not Provided

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00440986
CMHHPE, HH1
No
Not Provided
San Filippo Neri General Hospital
Not Provided
Principal Investigator: Francesco Equitani, M.D. San Filippo Neri General Hospital
San Filippo Neri General Hospital
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP