Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01949467
Eligibility Criteria:
Inclusion Criteria for patients:
* Man or woman older than 18 years
* Subject having a liver iron overload greater than or equal to 100 umol /g dry liver weight, confirmed by MRI (done performed with body antenna and complete deactivation of the surface antenna) and / or by biochemical assay on liver biopsy, and related to dysmetabolic hepatosiderosis or ferroportin disease.
* The ferroportin disease will be retained when patients will present an hyperferritinemia without elevated transferrin saturation and a heterozygote mutation in the gene encoding ferroportin.
* A dysmetabolic hepatosiderosis will be retained following the usual diagnostic investigation including sequencing of the gene for ferroportin (mutation proven negative), if patients do not show any other cause of iron overload and hyperferritinemia is not related to excessive alcohol intake, non-metabolic liver cytolysis (hepatitis C virus, wilson, autoimmune hepatitis, ...), hemolysis, or inflammatory syndrome.
* Status towards the iron-depletive treatment : either no venesection performed (Dysmetabolic HepatoSiderosis and Ferroportin disease groups) or attack iron depletive treatment completed (Treated Dysmetabolic Hepatosiderosis and Treated Ferroportin Disease groups) with ferritin level less than 100 ng / ml, without anemia and with no venesection in the two last months.
* Having given a free and informed consent in writing
* Affiliate to the social security system.
Exclusion Criteria for patients:
* Alcohol consumption greater than 30g/d
* Chronic inflammatory disease.
* HIV, HCV or HBV Infection.
* Blood donation in the last three months.
* Infection during the previous seven days before testing
* Staying in altitude (\>1500 m) dating less than 2 months
* Night occupation or shift work.
* Pregnancy
* Exclusion period in the national register of persons suitable for biomedical research.
* Protected adults (judicial protection, guardianship and trusteeship) and persons deprived of liberty
Inclusion criteria for healthy volunteers:
* Man or woman older than 18 years.
* Body Mass Index between 18 and 25 kg/m².
* Non smoker or quit smoking for more than 6 months
* Examen clinique normal. Normal clinical examination
* Normal ECG.
* Normal values for routine laboratory tests : serum iron, tranferrin saturation, CBC, ferritin, blood cell count C-reactive protein, AST, ALT, GGT, HDL and LDL cholesterol, triglycerides.
* Having given a free and informed consent in writing
* Affiliate or beneficiary to the social security system.
Exclusion criteria for healthy volunteers :
* Progressive and/or chronic disease.
* Infection during the previous seven days before testing
* Drug use under 6 months.
* Alcohol consumption greater than 30g/d
* Medication ongoing or stopped from less than a week (except contraceptives).
* History of blood transfusion or martial treatment.
* Staying in altitude (\>1500 m) dating less than 2 months
* Night occupation or shift work.
* Known infection by hepatitis B or C.
* Positive serology for HIV.
* Blood donation in the last three months.
* Pregnancy.
* Exclusion period in the national register of persons suitable for biomedical research.
* Protected adults (judicial protection, guardianship and trusteeship) and persons deprived of liberty.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01949467
Study Brief:
Protocol Section:
NCT01949467