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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | |
| University of California, San Francisco | San Francisco | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Texas Children's Hospital | Houston | Texas | |
| Nirmal Hospital Private Limited | Surat | Gujarat | |
| Medanta -The Medicity | Gurgaon | Haryana | |
| Colors Children Hospital | Nagpur | Maharashtra | |
| SMS Medical College and Hospital | Jaipur | Rajasthan | |
| M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk | Lucknow | Uttar Pradesh | |
| 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 | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01651403 on ClinicalTrials.gov ↗ ← All trials in the USA