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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01911156
Eligibility Criteria:
Inclusion Criteria:
* Chronic hepatitis B (HBsAg positive \> 6 months)
* Currently on NA monotherapy and for ≥1 year prior to screening
* HBeAg negative with anti-HBe antibodies and HBV DNA undetectable at least once at 12 or more months prior to screening and at screening (HBV DNA assay should have lower limit of quantification of at least 50 IU/mL)
* Documented HBeAg positive before start of NA monotherapy
* Age \> 18 years
* Written informed consent
Exclusion Criteria:
* Treatment with any investigational drug within 30 days of screening
* Severe hepatitis activity as documented by ALT \>10x ULN
* Creatinine clearance \<70 ml/min
* Presence of cirrhosis as documented by biopsy within 5 years, fibroscan \>9kPa, or fibrotest \>0.48
* Pre-existent neutropenia (neutrophils ≤1,000/mm3)
* Co-infection with hepatitis C virus and/or human immunodeficiency virus (HIV)
* Other acquired or inherited causes of liver disease
* Alpha fetoprotein \>50 ng/ml
* Hyper- or hypothyroidism
* Immune suppressive treatment within the previous 6 months
* Pregnancy, lactation
* Other significant medical illnesses that might interfere with this study
* Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
* Substance abuse (alcohol (≥80 g/day)and inhaled drugs (past 2 years)
* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01911156
Study Brief:
Protocol Section:
NCT01911156