LAST UPDATED
January 30, 2026
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
2 years - 11 years
Sex
All
Healthy Volunteers
No
Age
2 years - 11 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Chronic Hepatitis B
Gender
N/A
Date
December 2012 - August 2017
Study Type
Interventional
Study Phase
Phase 3
Product
Tenofovir DF, TDF Placebo
Eligibility information
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)
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
Locations
Locations (21)
University of California, San Francisco
San Francisco, California, United States, 94143
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
Lucknow, Uttar Pradesh, India, 226003
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, Romania, 011743
Fundeni Clinical Institute - Constantinesco
Bucharest, Romania, 022328
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology
Craiova, Romania, 200515
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial