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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT03463369
Eligibility Criteria:
Inclusion Criteria:
* Has chronic hepatitis B virus envelope antigen (HBeAg) negative hepatitis B virus (HBV) infection documented by a positive hepatitis B virus surface antigen (HBsAg) test and/or detectable HBV deoxyribonucleic acid (DNA) at least 6 months prior to the screening visit
* Is on a stable treatment with one of the approved oral nucleos(t)ide analogs (NA) polymerase inhibitors tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir for greater than or equal to (\>=)12 months prior to screening. A history of switching between the above treatments is acceptable as long as it was not triggered by virologic failure
* Must demonstrate HBV DNA levels less than (\<)60 international unit/milliliter (IU/mL) on 2 occasions separated by greater than (\>)6 months (of which one can be the screening assessment).
* Has HBsAg levels at screening between 100 IU/mL and 10,000 IU/mL
* Has normal alanine aminotransferase (ALT) levels for at least 6 months prior to baseline with no documented measurement exceeding 1.25 times upper limit of normal \[ULN\]). Minimal requirement is documentation of two ALT results within the year prior to baseline of which one can be the screening assessment.
Exclusion Criteria:
* Presence of advanced hepatic fibrosis or cirrhosis in 1 of the assessments below done less than or equal to (\<=)6 month prior to baseline: a. Metavir score 3 or 4 in a liver biopsy OR b. Fibroscan result of \>9 kilopascal (kPa) OR c. Acoustic Radiation Force Impulse (ARFI) result of \>=1.55 meter/second (m/s)
* Clinical signs or history of liver cirrhosis or hepatic decompensation:
1. Metavir score 4 in a historical biopsy OR
2. ascites, esophageal varices, or hepatic encephalopathy OR
3. documentation of one of the following laboratory abnormality within 12 months of screening:
i. direct (conjugated) bilirubin \>1.2 times upper limit of normal (ULN) OR ii. prothrombin time (PT) \>1.2 times ULN OR iii. serum albumin \<3.5 gram per deciliter (g/dL)
* Positive serology test at screening for any of the following:
1. anti-hepatitis B surface (ant-HBs) antibodies
2. HBeAg
3. anti-human immunodeficiency virus (HIV)-1 or anti-HIV-2 antibodies
4. anti-hepatitis A virus (HAV) immunoglobulin M (IgM) antibodies
5. anti-hepatitis C virus (ant-HCV) antibodies
6. anti-hepatitis D virus (anti-HDV) antibodies
* Participants with any evidence of liver disease of non-HBV etiology. This includes but is not limited to hepatitis A, C, or D virus infections (as above), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, non-alcoholic steatohepatitis or any other non-HBV liver disease considered clinically significant by the investigator
* Has a history of persistent or recurrent hyperbilirubinemia unless explained by known Gilbert's Disease
* History of blood disorders (bleeding problems or a blood clot, thalassemia major or sickle cell anemia).
* History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03463369
Study Brief:
Protocol Section:
NCT03463369