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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05099458
Eligibility Criteria:
Inclusion Criteria:
1. For all patients
* Compensated liver disease defined by the following criteria: Conjugated bilirubin level ≤ 1.2 x upper limit of normal (ULN), TP / INR ≤ 1.2 × ULN, platelets ≥ 150 x 109 / L, serum albumin ≥ 35 g / L, and no history of clinical hepatic decompensation (ascites, jaundice, encephalopathy, variceal hemorrhage) (results from a blood test dating up to 8 months before inclusion).
* Adequate haematological function: platelets ≥ 150x109 / L, Hb ≥ 12 g / dL (male) or ≥ 11 g / dL (female), white blood cells ≥4x109 / L and \<11x109 / L, except for ethnic neutropenia (these values must be obtained at least 8 months before inclusion)
* Male or female between 20 and 69 years of age, inclusive
* 18.5 ≤BMI ≤ 35 kg / m²
* Patients who dated and signed informed consent
2. For patients chronically infected with NUC treatment for more than 6 months:
* HBV DNA \<25 IU / mL
* HBsAg-positive (≥100 IU / mL)
* HBeAg-negative or positive
* ALT \<1.5x ULN
3. For chronically infected, untreated patients:
* HBsAg positive (≥100 IU / mL)
* negative or positive HBeAg
* HBV DNA\> 2000 IU / mL
* ALT \<2 x ULN
Exclusion Criteria:
* Use of steroids or other immunosuppressive agents that would affect the number and / or function of immune cells in the last 4 weeks
•,Any disease or other major medical disorder or condition that , that, in the judgment of the investigator, would interfere with results of the study (including, but not limited to: cancer, systemic lupus erythematosus, rheumatoid arthritis or other autoimmune disease, etc. ...)
* Major surgery or traumatic injury (including blood transfusion) in the last 4 weeks
-• Use of an experimental drug in the last 12 weeks
* Positive test for Hepatitis C, HIV, Hepatitis D, or Hepatitis A (anti-HAV IgM) at the time of inclusion
* Significant acute infection such as influenza or other clinically significant illness in the last 2 weeks
* History of drug abuse in the last year
* positive pregnancy test for women of childbearing age
* Breast-feeding women
* Patients presenting:
1. a medical history or signs of cirrhosis defined by a biopsy result or any other non-invasive validated test showing cirrhosis, OR
2. Either during the selection visit: a transient elastography value ≥ 10.5 kPa OR a Fibrotest® / Fibrosure® score ≥ 0.48 and an APRI score ≥1 .
Note: If a biopsy or a non-invasive test for cirrhosis has never been performed in the patient, then the medical examinations described in b) must be performed during the selection visit.
* History of ascites, digestive hemorrhage and / or encephalopathy
* Any co-morbidity that could lead to liver damage as judged by the investigator (excessive alcohol consumption, hemochromatosis, Wilson's disease, autoimmune hepatitis, inflammatory colitis ...)
* Patients unable or unwilling to comply with the protocol requirements
* Patient unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT05099458
Study Brief:
Protocol Section:
NCT05099458