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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT02985450
Eligibility Criteria:
Inclusion Criteria:
* Subjects 18-60 years of age, who provide signed informed consent
* Diagnosis of NAFLD/NASH according to expert assessment (by imaging, TE, abnormal lab tests and/or liver biopsy)
* No evidence of prior infection or immunity to hepatitis B (negative HBsAg, anti-HBs, anti-HBc).
Exclusion Criteria:
* Subjects \< 18 years of age,
* Subjects who refused vaccination
* Have documented immunity / prior exposure to hepatitis B (i.e., positive for ant-HBs, anti-HBc, HBsAg)
* Pregnancy
* HIV-positive
* Decompensated cirrhosis (i.e., Child-Pugh Class B or C) due to impact on immune response.
* Subjects \>60 y will be excluded, due to effect of age and reduced response to HBV vaccination.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02985450
Study Brief:
Protocol Section:
NCT02985450