Back to resultsClinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Primary Purpose
Hereditary Hemochromatosis
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Eritrocytoapheresis
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Hemochromatosis focused on measuring Clinical Management, Phlebotomy, Eritrocytoapheresis
Eligibility 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
Sites / Locations
- Department of Transfusion Medicine-San Filippo Neri General Hospital
Outcomes
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
Full Information
NCT ID
NCT00440986
First Posted
February 26, 2007
Last Updated
February 28, 2007
Sponsor
San Filippo Neri General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00440986
Brief Title
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Official Title
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
San Filippo Neri General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemochromatosis
Keywords
Clinical Management, Phlebotomy, Eritrocytoapheresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Eritrocytoapheresis
Primary Outcome Measure Information:
Title
To prospectively determine the best choice of tretment in HH
Title
To evaluate the global outcome according to treatment choice
Secondary Outcome Measure Information:
Title
To evaluate the outcome of specific clinical features according to treatment choice
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Equitani, M.D.
Organizational Affiliation
San Filippo Neri General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Transfusion Medicine-San Filippo Neri General Hospital
City
Rome
ZIP/Postal Code
00135
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
15175440
Citation
Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. doi: 10.1056/NEJMra031573. No abstract available.
Results Reference
background
PubMed Identifier
17959863
Citation
Equitani F, Fernandez-Real JM, Menichella G, Koch M, Calvani M, Nobili V, Mingrone G, Manco M. Bloodletting ameliorates insulin sensitivity and secretion in parallel to reducing liver iron in carriers of HFE gene mutations. Diabetes Care. 2008 Jan;31(1):3-8. doi: 10.2337/dc07-0939. Epub 2007 Oct 24.
Results Reference
derived
Learn more about this trial
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
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