Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Chronic Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT01651403
- Run by
- Gilead Sciences
- People needed
- 90
- Starts
- 2012-12-06
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-01-30
Who can join
Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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