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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01651403
Eligibility Criteria:
Key Inclusion Criteria:
* Male or Female, 2 to \< 12 years of age
* Weight ≥ 10 kg
* Chronic HBV infection ≥ 6 months
* Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
* HBV Viral Load ≥ 100,000 copies/mL
* Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
* Creatinine Clearance ≥ 80 mL/min/1.73m\^2
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3, hemoglobin ≥ 10 g/dL
* Negative pregnancy test at screening
* No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)
Key Exclusion Criteria:
* Pregnant or lactating
* Decompensated liver disease
* Received interferon therapy within 6 months of screening
* Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
* Alpha-fetoprotein levels \> 50 ng/mL
* Evidence of hepatocellular carcinoma (HCC)
* Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Chronic liver disease not due to HBV
* History of significant renal, cardiovascular, pulmonary, neurological or bone disease
* Long term non-steroidal, anti-inflammatory drug therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
11 Years
Study:
NCT01651403
Study Brief:
Protocol Section:
NCT01651403