Summary

for people ages 2-11 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Philip Rosenthal

Description

Summary

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

Official Title

A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection

Keywords

Chronic Hepatitis B Infection Hepatitis Hepatitis B HBV Infection Communicable Diseases Hepatitis A Hepatitis, Chronic Hepatitis B, Chronic Tenofovir Tenofovir DF

Eligibility

For people ages 2-11

Key Inclusion Criteria:

  • Male or Female, 2 to < 12 years of age
  • Weight ≥ 10 kg
  • Chronic HBV infection ≥ 6 months
  • 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/1.73m2

  • Absolute neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 10 g/dL

  • Negative pregnancy test at screening
  • No prior tenofovir DF therapy (subjects may have received prior interferon‑alfa and/or other oral anti‑HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; subjects 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 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

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Phoenix Children's Hospital
    Phoenix Arizona 85016 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT01651403
Phase
Phase 3
Lead Scientist
Philip Rosenthal
Study Type
Interventional
Last Updated
September 18, 2018