Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Tenofovir DF; TDF Placebo
Intervention description: Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight).
Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.; Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily.
Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.
Intervention MeSH terms: Tenofovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the antiviral efficacy of tenofovir
      disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to <
      12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.
    

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