Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

• Status: Active, not recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

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