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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03681132
Eligibility Criteria:
Inclusion Criteria:
* Adults (18-70 years) with HBeAg negative chronic hepatitis B
* HBeAg negative at start of antiviral therapy
* Treated minimum 2 years with either tenofovir or entecavir without interruption (i.e. no self-reported episodes of ≥2 weeks off therapy)
* Full viral suppression \>2 years: at least 3 measurements at least 6 months apart with at least 24 months between the first and last measurement.
* Most recent liver fibrosis assessment, performed within the past 12 months, does not show advanced fibrosis (i.e. Metavir score \<F3 or Fibroscan \<9 kPa). For the (few) patients who lack pre-treatment fibrosis assessment, a more conservative Fibroscan threshold of \<8 kPa will apply.
Exclusion Criteria:
* A history of decompensated liver disease, either by clinical signs (ascites, encephalopathy, portal hypertension, jaundice) or suggestive laboratory results (total bilirubin \>38 umol/L, INR \>1.5, platelets \<75,000/mm3, serum albumin \<30 g/L).
* Any previous diagnosis of cirrhosis, either by liver biopsy (Metavir score F4) or elastography (Fibroscan \>12 kPa). Elastography results with concomitant ALT \>200 U/L are not considered.
* Previous hepatocellular carcinoma (HCC).
* Co-infections with HIV, hepatitis C or hepatitis D.
* Other disease or medication that can interfere with the study (e.g. ongoing alcohol or illicit drug abuse, immunosuppressive medication, other active liver disease, or any other condition which in the opinion of the physician is incompatible with participation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03681132
Study Brief:
Protocol Section:
NCT03681132