Effect of Transferrin Saturation on Quality of Life in Haemochromatosis Patients

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

This study tests if adjusting bloodletting treatment based on transferrin saturation levels can improve the quality of life for people with HFE haemochromatosis compared to standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rennes University Hospital (Academic / other)
• Locations: 12 sites (Bobigny and 11 other locations)
• Trial ID: NCT04779593 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of transferrin saturation guided maintenance treatment on the quality of life of patients with HFE haemochromatosis. Patients who have been in maintenance treatment for at least one year will be randomized into two groups: one receiving treatment based on current guidelines and the other based on transferrin saturation levels. The study will involve regular bloodletting and assessments of iron metabolism parameters, as well as quality of life questionnaires. The aim is to determine if a more tailored approach to bloodletting improves patient outcomes compared to standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with C282Y homozygous HFE haemochromatosis who have completed the initial treatment phase and have been in maintenance treatment for at least one year.

Not a fit: Patients with chronic hematological conditions, uncontrolled chronic blood loss, or those currently undergoing treatment with iron chelators or erythroid growth factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life for patients with HFE haemochromatosis by optimizing their maintenance treatment.

How similar studies have performed: While the specific approach of transferrin saturation guided treatment is novel, similar studies have shown that tailored treatment strategies can improve patient outcomes in other conditions.

Eligibility criteria

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.

Where this trial is running

Bobigny and 11 other locations

• Hopital Avicenne — Bobigny, France (Recruiting)
• CHU Dupuytren — Limoges, France (Recruiting)
• GHBS site du Scorff — Lorient, France (Recruiting)
• GHRMSA - Hôpital Emile Muller — Mulhouse, France (Recruiting)
• CHR Orléans — Orléans, France (Recruiting)
• Hôpital Européen Georges Pompidou — Paris, France (Not_yet_recruiting)
• CHU Rennes — Rennes, France (Recruiting)
• CH Yves le Foll — Saint-Brieuc, France (Recruiting)
• CH de St Malo — St-Malo, France (Recruiting)
• Hôpital Rangueil — Toulouse, France (Recruiting)
• Centre hospitalier Bretagne Atlantique — Vannes, France (Recruiting)
• Hôpital Paul Brousse — Villejuif, France (Recruiting)

Conditions Haemochromatosis