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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

240

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

12 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress88%

Jul 2021Jan 2027

First Submitted

Initial submission to the registry

February 2, 2021

Completed

29 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed

4 months until next milestone

Study Start

First participant enrolled

July 2, 2021

Completed

5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5.5 years

First QC Date

February 2, 2021

Last Update Submit

January 16, 2023

Conditions

Haemochromatosis

Outcome Measures

Primary Outcomes (1)

The primary evaluation criteria is the Physical Component Score of the SF-36 questionnaire at the end of the study period (two years)
The primary evaluation criteria is the Physical Component Score of the SF-36 questionnaire at the end of the study period (two years). Physical Component score of the SF-36 has been chosen because SF-36 it is a widely validated and reproducible questionnaire, and this component is best susceptible to reflect both fatigue and joint involvement.
At Month 24

Secondary Outcomes (11)

the AIMS2- SF (short form of the Arthritis Impact Measurement Scales 2) questionnaire
at Day 0, Month 12 and Month 24 follow-up visit
the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire
at Day 0, Month 12 and Month 24 follow-up visit
Evolution of the Mental Component Score of the SF-36 questionnaire
At Month 24
Evolution of the Physical Component Score of the SF-36
at Day 0, Month 12 and Month 24 follow-up visit
Evolution of the Mental Component Score of the SF-36
at Day 0, Month 12 and Month 24 follow-up visit
+6 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

Patients treated with bloodletting according to "transferrin saturation and serum ferritin".

Other: Clinical examinationOther: SF36 questionnaireOther: AIMS2_SF questionnaireOther: WOMAC questionnaireOther: EQ-5D-5L questionnaireBiological: Blood Sample Complete blood countBiological: Blood Sample Iron panelBiological: Blood Sample Fasting GlucoseBiological: Blood sample lipid panelBiological: Blood sample liver panelBiological: Blood sample C reactive proteinBiological: BioBankOther: Medico-economicalProcedure: Bloodletting - experimental group

control group

ACTIVE COMPARATOR

Patients treated with bloodletting according to current guidelines "ferritin alone"

Other: Clinical examinationOther: SF36 questionnaireOther: AIMS2_SF questionnaireOther: WOMAC questionnaireOther: EQ-5D-5L questionnaireBiological: Blood Sample Complete blood countBiological: Blood Sample Iron panelBiological: Blood Sample Fasting GlucoseBiological: Blood sample lipid panelBiological: Blood sample liver panelBiological: Blood sample C reactive proteinProcedure: Bloodletting - control groupBiological: BioBankOther: Medico-economical

Interventions

Clinical examinationOTHER

Clinical data will be recorded (general clinical examination, height, weight, blood pressure,heart beat, alcohol and tobacco consumption, antecedent) as well as concurrent medication at each follow-up visit.