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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT07185360
Eligibility Criteria:
Volunteers without liver disease
\- Inclusion criteria: Major
Exclusion Criteria:
* Known liver disease
* Active cancer
* Viral or bacterial infection within 2 weeks of inclusion (respiratory, dermatological, urinary, digestive, etc.)
* Transfusion in the month preceding inclusion
* Current participation or less than 3 months' participation in a therapeutic interventional trial
* Absence of signed informed consent
* Not affiliated to a social security scheme
* Pregnant women
* Person under guardianship or trusteeship
Diabetic patients with F3/F4 fibrosis recruited and followed prospectively
Inclusion criteria:
* Patient aged 18 or over
* Type 2 diabetic (ADA/WHO criteria recalled in section 20.5)
* Hepatic fibrosis stage F3/F4 on liver biopsy or hepatic elasticity \> 10 kPa
Exclusion criteria:
Vulnerable person: a person deprived of liberty by a judicial or administrative decision, or under psychiatric care, and a person admitted to a health or social institution for purposes other than research.
* Protected adult
* Not affiliated to or not benefiting from a social security scheme
* Pregnant or breast-feeding women
* Absence of signed informed consent
* Illness linked to other etiologies:
* Alcoholic liver disease
* Current hepatitis B virus infection
* Current hepatitis C virus infection
* Autoimmune hepatitis according to according to AASLD and EASL recommended criteria
* Transferrin saturation \>50%
* Alpha antitrypsin ZZ or SZ type deficiency
* Wilson's disease
* Liver transplant patients
* Ultrasound obstruction of blood vessels or bile ducts (on routine ultrasound). If nothing is mentioned on the report, it is considered that there is no obstruction of the blood vessels or bile ducts).
* Current participation or less than 3 months' participation in a therapeutic interventional trial
Patients with liver disease :
Inclusion criteria:
* Major
* Child-Pugh A, B or C cirrhosis, diagnosed on the basis of histological evidence or liver elasticity \> 15 kPa or a combination of biological and radiological signs.
Exclusion criteria:
* Presence of one of the following diseases in the 15 days prior to inclusion: acute renal failure, bacterial infection (proven or suspected on clinico-biological criteria), digestive bleeding,
* alcoholic hepatitis in the month prior to inclusion
* Previous porto-systemic shunt, liver transplantation, primary sclerosing cholangitis, primary biliary cholangitis, Budd-Chiari syndrome
* Active or past hepatocellular carcinoma
* Active extrahepatic neoplasia,
* Current participation or less than 3 months' participation in a therapeutic interventional trial
* Absence of signed informed consent
* Non affiliation to a social security scheme
* Pregnant or breast-feeding
* Person under guardianship or trusteeship
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07185360
Study Brief:
Protocol Section:
NCT07185360