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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
Sponsor: Gilead Sciences
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
Conditions
Interventions
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.
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