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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02981602
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years
* Chronic HBV infection ≥6 months (e.g., positive for serum HBsAg ≥ 6 months)
* Plasma HBV DNA ≥ 2 x 1000 IU/mL (HBV DNA adequately suppressed for exploratory nucleos(t)ide analogue experienced cohort)
* Serum HBsAg ≥ 50 IU/mL
* Exploratory nucleos(t)ide analogue experienced cohort only: currently taking and have been taking tenofovir or entecavir without changes in drug, dose level and/or frequency of administration for ≥ 12 months and expect to continue taking without change through to the end of their participation in this study
Exclusion Criteria:
* Current or prior receipt of anti-HBV nucleos(t)ide analogue therapy. Patients who have failed prior interferon treatment, greater than 6 months prior to Screening, may be evaluated for possible participation in the study (not applicable for exploratory nucleos(t)ide analogue experienced cohort)
* History of liver cirrhosis and/or evidence of cirrhosis as determined by any of the following:
1. Liver biopsy (i.e., Metavir Score F4) within 2 years of Screening, or
2. Fibroscan \> 12 KPa, within 12 months of Screening, or
3. AST-to-Platelet Index (APRI) \> 2 and Fibrosure result \> 0.7 within 12 months of Screening For patients without a test for cirrhosis in the above timeframes, Fibroscan, or APRI and Fibrosure, may be performed during the screening period to rule out cirrhosis
* History of liver failure as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices
* History of liver disease other than Hepatitis B
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
* BMI \> 35 kg/m2
* History of, or suspected presence of vasculitis
* Received solid organ or bone marrow transplant
* Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone)
* Diagnosed hepatocellular carcinoma or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein ≥ 200 ng/mL. If the screening alpha-fetoprotein is ≥ 50 ng/mL and \< 200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization
* Clinically-significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination
* History of bleeding diathesis or coagulopathy
* History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa)
* History of excess alcohol consumption within 6 months of Screening
* History of drug abuse or dependence, or recreational use of drugs: within 3 months of Screening for soft drugs (such as marijuana) and within 1-year of Screening for hard drugs (such as cocaine, phencyclidine \[PCP\])
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02981602
Study Brief:
Protocol Section:
NCT02981602