Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological, Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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 proton pump inhibitors are widely used as chronic medication, and because they can significantly modify iron absorption, patients will be stratified according to the use of proton pump inhibitors and gender. A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients. Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group (patients treated with bloodletting according to current guidelines ferritin alone versus patients treated with bloodletting according to transferrin saturation and serum ferritin).Blood count and iron metabolism parameters will be performed at each bloodletting and follow-up visits. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit. Volume and schedule for bloodlettings will be determined according to guidelines specifically designed for this study to assure harmonization of treatment management, and centrally validated through the recording of the biological tests in the electronic Case Report Form which will provide the investigator with the volume and schedule of the next bloodletting. There will be two ways of treatment modification: either change of schedule or volume of bloodletting. Patients will undergo follow-up visit every six months with clinical examination, questionnaires at J0, M12 and M24 (SF-36; AIMS2-SF, WOMAC, EQ-5D-5L), and biological test. For health economics analysis, data will be obtained thanks to a dedicated extraction from SNDS database SNDS database will allow to gather hospital stays, visits, and other healthcare-related costs as well as vital status (date (month/year) of death) and cause of death. A de-identified copy of the clinical database, restricted to the relevant variables, will be sent for semideterministic matching purpose with SNDS extraction using four key variables: gender, same date (month/year) of birth, same date (day/month/year) of visit for bloodletting; pending, of course, regulatory authorization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
France
Hopital Avicenne
RECRUITING
Bobigny
CHU Dupuytren
RECRUITING
Limoges
GHBS site du Scorff
RECRUITING
Lorient
GHRMSA - Hôpital Emile Muller
RECRUITING
Mulhouse
CHR Orléans
RECRUITING
Orléans
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
CH Yves le Foll
RECRUITING
Saint-brieuc
CH de St Malo
RECRUITING
St-malo
Hôpital Rangueil
RECRUITING
Toulouse
Centre hospitalier Bretagne Atlantique
RECRUITING
Vannes
Hôpital Paul Brousse
RECRUITING
Villejuif
Time Frame
Start Date: 2021-07-02
Estimated Completion Date: 2027-01
Participants
Target number of participants: 240
Treatments
Experimental: experimental group
Patients treated with bloodletting according to transferrin saturation and serum ferritin.
Active_comparator: control group
Patients treated with bloodletting according to current guidelines ferritin alone
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov

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