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New treatment option for Hereditary Haemorrhagic Telangiectasia
Official title Immunological Effects of Iron Supplementation in HHT Disease
ClinicalTrials.gov ID: NCT07111598
What this study is testing
What is Blood test at D0?
Blood test at D0 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hereditary haemorrhagic telangiectasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hereditary haemorrhagic telangiectasia (HHT), is a rare genetic vascular disorder with autosomal dominant inheritance. Its prevalence is estimated at approximately 1 in 6,000 individuals in France.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
You likely can't join if
- 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...
- Pregnant, postpartum, or breastfeeding women.
- Minors.
See the full eligibility 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
- 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 treatment clinical trial with an exclusion period still in effect at the time of pre-inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Bron, Rhone, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, Rhone, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.