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

NCT01651403 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-30

Study results available
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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.

Conditions

Interventions

DRUG

Tenofovir DF

* Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg.

DRUG

TDF Placebo

* Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-06
Primary Completion
2017-08-07
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • India
  • Romania
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651403 on ClinicalTrials.gov