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Iron pills may weaken immunity in rare bleeding disorder

NCT ID NCT07111598

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Recruiting now This study
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how iron supplements, often given for anemia, affect the immune system in people with Hereditary Haemorrhagic Telangiectasia (HHT), a rare genetic disorder that causes frequent nosebleeds and abnormal blood vessels. About 155 adults with HHT will be divided into groups based on whether they take iron by mouth, through a vein, or not at all. Researchers will measure changes in immune cells to understand if iron helps or harms the body's defenses.

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Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 155 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For all three groups: * Adult patient diagnosed with HHT (meeting 3 or 4 Curaçao criteria). * Documented pathogenic mutation in one of the following genes: ENG, ACVRL1, or MADH4. * Patient enrolled in the CIROCO cohort. * Written informed consent freely given and signed by the patient. * Patient covered by a social security scheme or equivalent. * Routine biological follow-up for HHT performed within the 15 days preceding the inclusion visit (complete blood count, reticulocytes, ferritin, CRP, calcium, phosphorus). * Specific to Group 1: * Ferritin \> 25 µg/L * No iron supplementation (oral or intravenous) in the past 3 months * No red blood cell transfusion in the past 3 months * Specific to Group 2: * Ferritin \> 25 µg/L * Ongoing oral iron therapy, or at least one intravenous iron infusion, or at least one red blood cell transfusion within the past 3 months * Specific to Group 3: * Ferritin \< 25 µg/L * No iron supplementation (oral or intravenous) in the past 3 months * No red blood cell transfusion in the past 3 months Exclusion Criteria: * Patients with hemoglobin levels \< 90 g/L. * Patients with active cancer or recent cancer remission (\< 3 months) that may alter the immune profile. * Patients with an active infection or recent infection recovery (\< 3 months) that may alter the immune profile. * Patients with an autoimmune or autoinflammatory disease, either active or recently treated (\< 3 months), requiring immunosuppressive therapy and potentially altering the immune profile. * Pregnant, postpartum, or breastfeeding women. * Minors. * Individuals deprived of liberty by judicial or administrative decision. * Individuals undergoing psychiatric care. * Individuals admitted to a healthcare or social institution for reasons other than research participation. * Adults under legal protection (guardianship, curatorship). * Individuals participating in another interventional clinical trial with an exclusion period still in effect at the time of pre-inclusion.

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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.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Hôpital Femme-Mère-Enfant

    RECRUITING

    Bron, Rhone, 69500, France

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