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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003074-26-IT

Enrollment

Registered

2007-06-15

Start date

2007-06-20

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of hereditary emocromatosis. MedDRA version: 6.1 Level: SOC Classification code 10005329

Interventions

Trade Name: IRON 65 Pharmaceutical Form: Tablet INN or Proposed INN: ferrous sulfate natura made Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 65-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026