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Summary

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

Description

Summary

This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B infection. While studies have shown significant virologic response in adults and adolescents, the effect in children is not well established. This study will provide valuable data that can help establish the efficacy and safety profiles of TDF in children. The study will consist of 48 weeks of blinded randomized treatment, after which participants will switch to open-label TDF treatment for an additional 144 weeks.

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 Tenofovir

Eligibility

For people ages 2–11

Key Inclusion Criteria:

  • Male or Female, 2 to < 12 years of age
  • Weight ≥ 10kg
  • Chronic HBV infection ≥ 6 months
  • HBeAg-positive or HBeAg-negative
  • HBV Viral Load ≥ 100,000 copies/mL
  • Alanin aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
  • Creatinine Clearance ≥ 80 mL/min
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 10g/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

  • Phoenix Children's Hospital
    Phoenix, Arizona, 85016, United States
  • University of Colorado School of Medicine
    Aurora, Colorado, 80045, United States
  • Texas Children's Hospital
    Houston, Texas, 77030, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, 45229, United States
  • Kyungpook National University
    Daegu, 700-721, Korea, Republic of
  • Severance Children's Hospital
    Seoul, 120-752, Korea, Republic of
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan-si, 626 770, Korea, Republic of
  • Grigore Alexandrescu Emergency Clinical Hospital for Children
    Bucharest, 011743, Romania
  • Fundeni Clinical Institute - Constantinesco
    Bucharest, 022328, Romania
  • "Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisology
    Craiova, 200515, Romania
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
  • Medanta -The Medicity
    Gurgaon, Haryana, 122 001, India
  • Colors Children Hospital
    Nagpur, Maharashtra, 440012, India
  • M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk
    Lucknow, Uttar Pradesh, 226003, India
  • St. John Hospital & Medical Center
    Bangalore, 560034, India
  • Nirmal Hospital Private Limited
    Gujarat, 395 002, India
  • SMS Medical College and Hospital
    Rajasthan, 302004, India

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
August 1, 2017