Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection



Status:Active, not recruiting
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 11
Updated:9/21/2018
Start Date:December 6, 2012
End Date:May 2030

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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

The primary objective of this study is to evaluate the antiviral efficacy of tenofovir
disoproxil fumarate (TDF) versus placebo in pediatric population (aged 2 to < 12 years at the
time of enrollment) with chronic hepatitis B (CHB) infection.


Key Inclusion Criteria:

- Male or Female, 2 to < 12 years of age

- Weight ≥ 10 kg

- Chronic HBV infection ≥ 6 months

- 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 (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
We found this trial at
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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San Francisco, California 94143
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Surat, Gujrat 39500
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