An interventional study of Clinical examination and SF36 questionnaire in Haemochromatosis, sponsored by Rennes University Hospital. Active, not recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment
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Among 17 studies in Hemochromatosis with a site in France — none open to participants now, 2 under way, none of them phase 3. Hemochromatosis · France.
Among the 17 studies in Hemochromatosis with a site in France, this one is the 2nd largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2021, is one of 4 with no phase, and was the 16th registered.
55 studies on the registry are indexed under Hemochromatosis; 4 are open to participants now.
Browse Hemochromatosis studies →None of the 17 studies in Hemochromatosis with a site in France is open now. The open studies under Hemochromatosis, anywhere →
Of the 4 Hemochromatosis studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 1
First in 2000; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 239 is above the median of 61 across 30 interventional studies indexed under Hemochromatosis.
Median enrollment 62 across the 11 interventional studies, 66 across the 6 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
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4 of 17 have an industry lead sponsor. The 8 most frequent:
Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Rennes University Hospital has 9 studies filed under Hemochromatosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Hemochromatosis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04779593Rennes University HospitalImpact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis | 2027-01 |
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Among the 17 studies in Hemochromatosis with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated with bloodletting according to "transferrin saturation and serum ferritin".
Other: Clinical examination · Other: SF36 questionnaire · Other: AIMS2_SF questionnaire · Other: WOMAC questionnaire · Other: EQ-5D-5L questionnaire · Biological: Blood Sample Complete blood count · Biological: Blood Sample Iron panel · Biological: Blood Sample Fasting Glucose · Biological: Blood sample lipid panel · Biological: Blood sample liver panel · Biological: Blood sample C reactive protein · Biological: BioBank · Other: Medico-economical · Procedure: Bloodletting - experimental group
Patients treated with bloodletting according to current guidelines "ferritin alone"
Other: Clinical examination · Other: SF36 questionnaire · Other: AIMS2_SF questionnaire · Other: WOMAC questionnaire · Other: EQ-5D-5L questionnaire · Biological: Blood Sample Complete blood count · Biological: Blood Sample Iron panel · Biological: Blood Sample Fasting Glucose · Biological: Blood sample lipid panel · Biological: Blood sample liver panel · Biological: Blood sample C reactive protein · Procedure: Bloodletting - control group · Biological: BioBank · Other: Medico-economical
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.
At D0, M12 and M24. This 36 item patient reported survey of patient's health is the most commonly used and validated health survey instrument for appraising quality of life. Items are grouped in 8 scaled scores exploring multiple dimension of global health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life).
At D0, M12 and M24. The Arthritis Impact Measurement Scales 2 Short Form (AIMS2-SF) is a specific tool to measure changes in global health, pain, mobility and social function in patients with arthritis. It was described in 1992 in patients with rheumatoid arthritis and osteoarthritis and include 26 items that are summarized in scales according to a predefined scoring system: mobility, physical activity (walking, bending, lifting), dexterity, household activity (managing money and medications, housekeeping), social activities, activities of daily living, pain, depression, and anxiety. The French translation has been validated and this questionnaires has been widely used in the rheumatology field to assess quality of life of patients with arthritis. Because HFE related arthropathy is very similar to osteoarthritis this questionnaire is ought to be adequate in this setting.
At D0, M12 and M24. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used questionnaires specifically assessing lower limb (hips and knee) osteoarthritis. It measures five items for pain, two for stiffness and 17 for functional limitation and had been translated in French.
At D0, M12 and M24. The EQ-5D is a standardized instrument which evaluates the generic quality of life (http://www.euroqol.org/). It is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given to EQ-5D permit to find 243 health states that can be converted into utility score anchored at 0 for death and 1 for perfect health. EQ-5D is an instrument developed in Europe, widely used in cost-utility analysis. It has been validated in a representative sample of French population.
Blood Sample Complete blood count at D0, M6, M12, M18 and M24/end follow-up visit
Blood Sample Iron panel (serum ferritin, serum iron and serum transferrin to determine transferrin saturation according to randomization group (at M6, M12 and M18) at D0, M6, M12, M18 and M24/end follow-up visit and at each bloodletting.
Blood Sample Fasting Glucose at D0 and M24/end follow-up visit
Blood sample lipid panel (total cholesterol, triglycerides, HDL, LDL) at D0 and M24/end follow-up visit
Blood sample liver panel (total bilirubin, Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma-Glutamyl Transferase) at D0 and M24/end follow-up visit
Blood sample C reactive protein at D0 and M24/end follow-up visit
Patients treated with bloodletting according to current guidelines (ferritin alone). Patient will undergo bloodletting with a goal of maintaining a serum ferritin equal or lower than 50 g/L according to current clinical practice guidelines (French and European).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. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit.
Blood sample will be collected for BioBank at D0, M12 and M24.
Medico-economic data will be collected at each follow up visit.
Patients treated with bloodletting according to "transferrin saturation and serum ferritin". Patients will undergo bloodletting with a goal of maintaining a serum transferrin saturation equal or lower than 50 % and a serum ferritin lower than the upper limit of the normal range (300 g/L for men and 200 g/L for women).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. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit.
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.
Time frame: At Month 24
the AIMS2- SF (short form of the Arthritis Impact Measurement Scales 2) questionnaire
Assessment of Arthropathy and joint pain related quality of life as assessed by the AIMS2- SF (short form of the Arthritis Impact Measurement Scales 2) questionnaire throughout the study, as performed at J0, M12 and M24 follow-up visit (every 12 months).
Time frame: at Day 0, Month 12 and Month 24 follow-up visit
the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire
Assessment of Arthropathy and joint pain related quality of life as assessed by the WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire throughout the study, as performed at J0, M12 and M24 follow-up visit (every 12 months).
Time frame: at Day 0, Month 12 and Month 24 follow-up visit
Evolution of the Mental Component Score of the SF-36 questionnaire
Evolution of the Mental Component Score of the SF-36 questionnaire between inclusion and the end of the study period (two years).
Time frame: At Month 24
Evolution of the Physical Component Score of the SF-36
Evolution of the Physical Component Score of the SF-36 throughout the study, as performed at J0, M12 and M24 follow-up visit (every 12 months).
Time frame: at Day 0, Month 12 and Month 24 follow-up visit
Evolution of the Mental Component Score of the SF-36
Evolution of the Mental Component Score of the SF-36 throughout the study, as performed at J0, M12 and M24 follow-up visit (every 12 months).
Time frame: at Day 0, Month 12 and Month 24 follow-up visit
Evolution of of the EQ-5D-5L score
Evolution of of the EQ-5D-5L score throughout the study, as performed at J0, M12 and M24 follow-up visit (every 12 months).
Time frame: at Day 0, Month 12 and Month 24 follow-up visit
Evolution of Serum ferritin and serum transferrin saturation
Evolution of Serum ferritin and serum transferrin saturation determined at each follow-up visit (every 6 months).
Time frame: Day 0, Month 6, Month 12, Month 18 and Month 24/follow-up visit
Occurrence of anaemia
Occurrence of anaemia defined as haemoglobin lower than 11g/dL at any follow-up visit.
Time frame: Day 0, Month 6, Month 12, Month 18 and Month 24/follow-up visit
Occurrence of malaise
Occurrence of malaise after a bloodletting procedure
Time frame: At Month 24
Total number of phlebotomy performed
Total number of phlebotomy performed by each patient during the study period.
Time frame: At Month 24
Incremental Cost-Effectiveness Ratio
Incremental Cost-Effectiveness Ratio (ICER) defined as the cost for QALY gained in the "transferrin saturation + ferritin" strategy versus "ferritin alone" strategy.
Time frame: At Month 24
Started Jul 2021 (actual). Primary completion is estimated for Jan 2027, 66 months after the start.
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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