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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/003994

Enrollment

100

Registered

2013-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pediatric Patients with Chronic Hepatitis B Infection

Interventions

Intervention1: Tenofovir Disoproxil Fumarate OR matching placebo - Tablets/ Powder: TDF tablet/ Matching placebo: 150mg, 200mg, 250mg and 300mg Frequency:Once daily Duration: 72 weeks Intervention2:

8mg to maximum 300mg. Frequency: Once daily Duration : 120 weeks Intervention3: Blinded Tenofovir DF: Tablet : For subjects = 17 kg - blinded tenofovir DF oral tablet Route of administration : Oral

Eligibility

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: •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

Design outcomes

Primary

Measure	Time frame
•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

Measure	Time frame
•Proportion of patients with HBeAg seroconversion at Week 72 •Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine, timeframe: Week 72 •Percent change from baseline in bone mineral density of lumbar spine, timeframe: Week 72 •Safety and Tolerability of Therapy, timeframe: up to Week 192 •Biochemical and serological responses , timeframe: Week 72 Viral Resistance, timeframe: Weeks 72, 144, 192 or Early DiscontinuationTimepoint: Week 72 Safety and Tolerability measure: up to Week 192 Viral Resistance: Weeks 72, 144, 192 or Early Discontinuation	—

Measure

Time frame

•Proportion of patients with HBeAg seroconversion at Week 72 •Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine, timeframe: Week 72 •Percent change from baseline in bone mineral density of lumbar spine, timeframe: Week 72 •Safety and Tolerability of Therapy, timeframe: up to Week 192 •Biochemical and serological responses , timeframe: Week 72 Viral Resistance, timeframe: Weeks 72, 144, 192 or Early DiscontinuationTimepoint: Week 72 Safety and Tolerability measure: up to Week 192 Viral Resistance: Weeks 72, 144, 192 or Early Discontinuation

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Countries

Bulgaria, India, Poland, Republic of Korea, Romania, Taiwan, United States of America

Contacts

Public ContactMrSunil Verma

Klinera Corporation India

safetyreporting@klinera.com2225091470

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026