Personalized bloodletting could ease life for iron overload patients
NCT ID NCT04779593
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a blood marker called transferrin saturation to guide bloodletting (removing blood) improves quality of life in people with HFE haemochromatosis, a genetic condition causing iron buildup. 239 adults already on maintenance bloodletting will be randomly assigned to standard care (guided by ferritin alone) or the new approach. Over two years, researchers will track physical health, joint pain, and fatigue using questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bloodletting (phlebotomy)
- What this could lead to
- If successful, this could lead to a more personalized bloodletting schedule that improves quality of life for people with haemochromatosis.
- What could go wrong
- This is a mid-stage study with 239 participants, so results may not apply to everyone. The intervention is already standard care, so major breakthroughs are unlikely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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239 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \- 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH Yves le Foll
Saint-Brieuc, France
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CH de St Malo
St-Malo, France
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CHR Orléans
Orléans, France
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CHU Dupuytren
Limoges, France
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CHU Rennes
Rennes, France
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Centre hospitalier Bretagne Atlantique
Vannes, France
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GHBS site du Scorff
Lorient, France
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GHRMSA - Hôpital Emile Muller
Mulhouse, France
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Hopital Avicenne
Bobigny, France
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Hôpital Européen Georges Pompidou
Paris, 75908, France
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Hôpital Paul Brousse
Villejuif, France
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Hôpital Rangueil
Toulouse, France