Proton pump inhibitors in the prevention of iron reaccumulation in patients with hereditary hemochromatosis

Phase 1

• Conditions: Hereditary hemochromatosis; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000603-32-NL
• Lead Sponsor: Annadalstichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-16
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Patient with hereditairy hemochromatosis, homozygous for c282Y currently treated with phlebotomy as maintenance therapy for at least 12 months with >/= phlebotomies per year.
Ferritin level between 50-100 ug/l at start of inclusion.
Age 18-75 years
Weight > 50kg
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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients receiving other therapies such as chelating therapy or forced diet
Obesitas (BMI > 35)
Patients who are mentally incapacitated
pregnancy; women expecting / planning to become pregnant during the study period.
Patients with a malignancy
Patients already on ppi treatment
patients experienced side effects ppi.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The difference between the number of phlebotomies (expressed as standardized units 500ml-per year) for the group taking ppi treatment compared to the group taking placebo;Secondary Objective: To determine quality of life (questionnaires), cost effectiveness (QUALY), patient compliance/ satisfaction, side effects due to phlebotomies and ppi.;Primary end point(s): Number of phleobotomies (expresses as standardized units-500ml-per year);Timepoint(s) of evaluation of this end point: After 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To determine quality of life (questionnaires), cost effectiveness (QUALY), patient compliance/ satisfaction, side effects due to phlebotomies and ppi.;Timepoint(s) of evaluation of this end point: After 12 months