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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01651403

Public ClinicalTrials.gov record NCT01651403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 9:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT01651403
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
90 participants

Conditions and interventions

Interventions

  • Tenofovir DF Drug
  • TDF Placebo Drug

Drug

Eligibility (public fields only)

Age range
2 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 5, 2012
Primary completion
Aug 6, 2017
Completion
Jun 30, 2027
Last update posted
Jan 29, 2026

2012 – 2027

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016
University of California, San Francisco San Francisco California 94143
Children's Hospital Colorado Aurora Colorado 80045
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Texas Children's Hospital Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01651403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 29, 2026 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01651403 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →