Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT01651403
PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2012-12-06

Completion Date

2027-07

Last Updated

2026-01-30

Healthy Volunteers

No

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.

Locations (21)

Phoenix Children's Hospital

Phoenix, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Texas Children's Hospital

Houston, Texas, United States

Nirmal Hospital Private Limited

Surat, Gujarat, India

Medanta -The Medicity

Gurgaon, Haryana, India

Colors Children Hospital

Nagpur, Maharashtra, India

SMS Medical College and Hospital

Jaipur, Rajasthan, India

M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk

Lucknow, Uttar Pradesh, India

St. John Hospital & Medical Center

Bangalore, India

Grigore Alexandrescu Emergency Clinical Hospital for Children

Bucharest, Romania

Fundeni Clinical Institute - Constantinesco

Bucharest, Romania

Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology

Craiova, Romania

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Kyungpook National University

Daegu, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Children's Hospital

Seoul, South Korea

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan