Status:
RECRUITING
Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis
Lead Sponsor:
Rennes University Hospital
Conditions:
Haemochromatosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients in maintenance treatment for HFE hemochromatosis since at least one year will be included in a two year study period and randomized in two groups experimental and control group. Because proto...
Eligibility Criteria
Inclusion
- \- Patients treated with iron chelators;
- Patients treated with erythroid growth factors (erythropoietin);
- Patient with excessive alcohol consumption (\> 20g/day and \> 30 g/day for women and men respectively);
- Patients with chronic haematological condition;
- Patients having uncontrolled chronic blood loss (of digestive or gynaecological origin);
- Patients with chronic kidney failure;
- Patients with a diagnosis of cancer or history of cancer in the last year;
- Pregnancy or breast feeding.
- Patient who are included in another research protocol
- Adults legally protected (judicial protection, guardianship, or supervision), persons deprived of their freedom.
- with C282Y homozygous HFE hemochromatosis;
- having finished the initial phase of HFE hemochromatosis treatment and in maintenance treatment for at least one year;
- having signed an informed consent form.
Exclusion
- Patients treated with iron chelators;
- Patients treated with erythroid growth factors (erythropoietin);
- Patient with excessive alcohol consumption (\> 20g/day and \> 30 g/day for women and men respectively);
- Patients with chronic haematological condition;
- Patients having uncontrolled chronic blood loss (of digestive or gynaecological origin);
- Patients with chronic kidney failure;
- Patients with a diagnosis of cancer or history of cancer in the last year;
- Pregnancy or breast feeding.
- Patient who are included in another research protocol
- Adults legally protected (judicial protection, guardianship, or supervision), persons deprived of their freedom.
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04779593
Start Date
July 2 2021
End Date
January 1 2027
Last Update
January 18 2023
Active Locations (12)
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1
Hopital Avicenne
Bobigny, France
2
CHU Dupuytren
Limoges, France
3
GHBS site du Scorff
Lorient, France
4
GHRMSA - Hôpital Emile Muller
Mulhouse, France