Phoenix Children’s Hospital Research
Institute (PCRI) Website Clinical Trial Listing
** Please complete and return to Shy Walker at
swalker@phoenixchildrens.com
Study Title: Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With
Chronic Hepatitis B Infection
Study Purpose:
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.
Study Summary:
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 72 weeks of blinded randomized treatment, after which
participants will switch to open-label TDF treatment for an additional 120 weeks.
Basic Eligibility Criteria:
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

Alanine 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/mm^3, 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)
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
Study Location(s):
Phoenix Children’s Hospital
Study Contact(s):
Michael Johnson, Research Coordinator
mjohnson7@phoenixchildrens.com