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Active, not recruiting Phase 3

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

NCT01651403 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2012-12-06
Last updated
2026-01-30

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

Tenofovir DF →TDF Placebo

Tenofovir DF: * 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.

TDF Placebo: * 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.

Study 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

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach) — Week 48
  • Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach) — Week 48

Trial sites (21)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona
University of California, San Francisco San Francisco California
Children's Hospital Colorado Aurora Colorado
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Texas Children's Hospital Houston Texas
Nirmal Hospital Private Limited Surat Gujarat
Medanta -The Medicity Gurgaon Haryana
Colors Children Hospital Nagpur Maharashtra
SMS Medical College and Hospital Jaipur Rajasthan
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk Lucknow Uttar Pradesh
St. John Hospital & Medical Center Bangalore India
Grigore Alexandrescu Emergency Clinical Hospital for Children Bucharest Romania
Fundeni Clinical Institute - Constantinesco Bucharest Romania
Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology Craiova Romania
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do
Kyungpook National University Daegu South Korea
Asan Medical Center Seoul South Korea
Samsung Medical Center Seoul South Korea
Severance Children's Hospital Seoul South Korea
National Taiwan University Hospital Taipei Taiwan
Taipei Veterans General Hospital Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01651403 on ClinicalTrials.gov ↗ ← All trials in South Korea