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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02992704
Eligibility Criteria:
Inclusion Criteria:
* Treatment naïve
* Documented HBsAg or HBV DNA positive for ≥ 6 months.
* Documented HBeAg negative and anti-HBe positive
* ALT ≤1xULN
* quantitative HBsAg \<1,000 IU/ml
* HBV DNA \<2x104 IU/mL at screening
* Absence of cirrhosis documented by liver biopsy or transient elastography within 6 months (Fibroscan®; Fibrosis stage \>2 (score ≥ 10Kpa) will not be eligible for this study.)
* Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
* Patient is able to give written consent prior to study start and to comply with the study requirements.
* Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken within 14 days of starting therapy
Exclusion Criteria:
* Patients who are currently on treatment with nucleoside/nucleotide analogues or have been treated for Hepatitis B in the past
* Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥ 10kpa)
* Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.
* Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin \>1.2x upper limit of normal (ULN), prothrombin time (PT) \>1.5xULN , serum bilirubin \<35g/L, or prior history of clinical hepatic decompensation as illustrated by presence of (eg. ascites, encephalopathy, variceal haemorrhage)
* Evidence of hepatocellular carcinoma
* Absolute neutrophil count \<1.5x10\^9/L or Hemoglobin \<12 g/L for men or \<11 g/L for women, or platelet count \< 90x10\^9/L
* History of depression or psychiatric disease
* Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) \>1.2 ULN or 0.8xLLN or thyroid dysfunction
* Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6 months before trial entry
* Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
* Malignant disease within 5 years of trial entry
* Women who are pregnant and who are not practicing adequate birth control measures, (defined as two methods of birth control with at least one barrier method) or who are lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02992704
Study Brief:
Protocol Section:
NCT02992704