Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infectio
- Conditions
- Health Condition 1: null- Pediatric Patients with Chronic Hepatitis B Infection
- Registration Number
- CTRI/2013/09/003994
- Lead Sponsor
- Gilead Sciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
•Male or female
•2 years to 12 years of age, consent of parent or legal guardian required
•Weight more than 10kg
•Chronic HBV infection more than 6 months
•HBeAg positive or HBeAg negative
•HBV Viral Load more than 100000 copies per mL
•ALT more than 1.5 of ULN at screening,
•Creatinine Clearance more than 80 mL min
•Absolute neutrophil count more than 1500mm3, hemoglobin more than 10.0g per dL
•Negative pregnancy test at screening
•No prior tenofovir DF therapy,subjects may have received prior interferon-alfa and or other oral antiHBV nucleoside nucleotide therapy, subjects must have discontinued interferonalfa therapy more than 6 months prior to screening, subjects experienced on other antiHBV nucleoside nucleotide therapy must have discontinued therapy more than 16 weeks prior to screening to avoid flare if randomized to the placebo arm.
•Pregnant or lactating
•Decompensated liver disease
•Received interferon therapy within 6 months of the Screening
•Received antiHBV nucleoside,nucleotide therapy within 16 weeks of the Screening
•Alphafetoprotein levels 50 ng per mL
•Evidence of hepatocellular carcinoma,HCC
•Coinfection with HIV, acute HAV, HCV, or HDV
•Chronic liver disease not due to HBV
•History of significant renal disease, cardiovascular, pulmonary, neurological or bone disease
•Long term nonsteroidal, antiinflammatory drug therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Proportion of patients with serum HBV DNA 400 copies/mL at Week 72Timepoint: •Proportion of patients with serum HBV DNA 400 copies/mL at Week 72
- Secondary Outcome Measures
Name Time Method •Proportion of patients with HBeAg seroconversion at Week 72 <br/ ><br>•Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine, timeframe: Week 72 <br/ ><br>•Percent change from baseline in bone mineral density of lumbar spine, timeframe: Week 72 <br/ ><br>•Safety and Tolerability of Therapy, timeframe: up to Week 192 <br/ ><br>•Biochemical and serological responses , timeframe: Week 72 <br/ ><br>Viral Resistance, timeframe: Weeks 72, 144, 192 or Early DiscontinuationTimepoint: Week 72 <br/ ><br>Safety and Tolerability measure: up to Week 192 <br/ ><br>Viral Resistance: Weeks 72, 144, 192 or Early Discontinuation <br/ ><br>