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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00116805
Eligibility Criteria:
Key Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for participation in this study:
* Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
* 18 through 69 years of age, inclusive
* Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
* HBeAg positive at screening
* Alanine aminotransferase (ALT) levels \> 2 × ULN and ≤ 10 × the upper limit of the normal range (ULN)
* Serum HBV DNA \> 1 million copies/mL at screening
* creatinine clearance ≥ 70 mL/min
* hemoglobin ≥ 8 g/dL
* neutrophils ≥ 1,000 /mL
* Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score \< 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
* Negative serum β-human chorionic gonadotropin (hCG)
* Nucleotide naïve, ie, no prior nucleotide (TDF or ADV) therapy for \> 12 weeks
* Nucleoside naïve, ie, no prior nucleoside (any nucleoside) therapy for \> 12 weeks
* Willing and able to provide written informed consent
* Liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
Key Exclusion Criteria:
A patient who meets any of the following exclusion criteria is not to be enrolled in this study:
* Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study; for males, condoms should be used and for females, a barrier contraception method should be used
* Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
* Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre-treatment biopsy
* Evidence of hepatocellular carcinoma (HCC), ie, α-fetoprotein \>50 ng/mL
* Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV)
* Significant renal, cardiovascular, pulmonary, or neurological disease
* Received solid organ or bone marrow transplantation
* Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
* Has proximal tubulopathy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT00116805
Study Brief:
Protocol Section:
NCT00116805