NCT00440986

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 26, 2007

Last Update Submit

February 28, 2007

Conditions

Hereditary Hemochromatosis

Keywords

Clinical ManagementPhlebotomyEritrocytoapheresis

Outcome Measures

Primary Outcomes (2)

  • To prospectively determine the best choice of tretment in HH

  • To evaluate the global outcome according to treatment choice

Secondary Outcomes (1)

  • To evaluate the outcome of specific clinical features according to treatment choice

Interventions

EritrocytoapheresisPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patiens newly diagnosed having Hereditary Hemochromatosis

You may not qualify if:

  • Age \< 18 yrs.
  • Not obese (BMI \<30)
  • Not consuming alchol beverages,
  • Not affected by systemic diseases and known hepatic viruses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Transfusion Medicine-San Filippo Neri General Hospital

Rome, 00135, Italy

Location

Related Publications (2)

  • 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.

    PMID: 15175440BACKGROUND

  • 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.

    PMID: 17959863DERIVED

MeSH Terms

Conditions

Hemochromatosis

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Francesco Equitani, M.D.

    San Filippo Neri General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

April 1, 2003

Study Completion

December 1, 2006

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

IT(1)