An observational study in Hemochromatoses, Genetic, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Rennes University Hospital · Observational
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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 one of 2 that started in 2017, is one of 6 observational ones, and was the 11th 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.
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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. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 260 is above the median of 70 across 19 observational 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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Observational study.
The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload.
Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia \<50 by performing weekly bleeds.
The second phase, called maintenance, aims to maintain this ferritinemia \<50 by performing bleeding every 1 to 6 months depending on the case.
The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels \<50. This could reflect an incomplete control of their disease, and leads us to raise two points:
Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .
Patients with genetic hemochromatosis HFE
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homozygous C282Y ;
Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ;
Quality of life questionnaire SF 36
Time frame: Through study completion, an average of 3 months
Biological markers : Transferrin Saturation Coefficient
Time frame: Through study completion, an average of 3 months
Ran from Apr 2017 to primary completion in Apr 2019, 23 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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