Study Details

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.

Participation Requirements

Age

2 Years - 11 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Chronic Hepatitis B

Gender

N/A

Date

December 2012 - August 2017

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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)

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

University of California, San Francisco

San Francisco, California, United States, 94143

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Texas Children's Hospital

Houston, Texas, United States, 77030

Nirmal Hospital Private Limited

Surat, Gujrat, India, 395 002

Medanta -The Medicity

Gurgaon, Haryana, India, 122 001

Colors Children Hospital

Nagpur, Maharashtra, India, 440012

SMS Medical College and Hospital

Jaipur, Rajasthan, India, 302004

M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk

Lucknow, Uttar Pradesh, India, 226003

St. John Hospital & Medical Center

Bangalore, India, 560034

Pusan National University Yangsan Hospital

Yangsan, Gyeongnam, Korea, Republic of, 50612

Kyungpook National University

Daegu, Korea, Republic of, 41944

Asan Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Severance Children's Hospital

Seoul, Korea, Republic of, 120-752

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

National Taiwan University Hospital

Taipei, Taiwan, 100

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

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

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