Oral iron challange on urinary excretion of hepcidin, the key iron regulatory hormone in hemochromatosis. - ND

Conditions: Treatment of hereditary emocromatosis.
MedDRA version: 6.1Level: SOCClassification code 10005329

Registration Number: EUCTR2007-003074-26-IT

Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

adult patients affected by hereditary emocromatosis, both male and female,at diagnosis or that in the past underwent iron depletion,at least 1 month after the last bleed.Also patients coming from study EPC/01 colud be enrolled in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients with advanced pathology with epatic insufficiency or epatic carcinoma, concomitant inflammatory or infective affection, concomitant hepatitis C or B,alcohol abuse, evidence of dismetabolic syndrome, pregnant woman, patients in therapy with antisecretive gastric drugs or protonic pump inhibitors.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the absence/reduction of hepcidin production , already observed at 24 hours in study EPC/01,in shorter times.;Secondary Objective: To confirm the absence/reduction of hepcidin production , already observed at 24 hours in study EPC/01,in shorter times.;Primary end point(s): to confirm the absence/reduction of hepcidin production , already observed at 24 hours in study EPC/01,in shorter times

Secondary Outcome Measures