Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection (NCT01651403)

🧪 Interventions in This Study

• Tenofovir DF (DRUG)
• TDF Placebo (DRUG)

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (21 Sites)

• 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,
• Grigore Alexandrescu Emergency Clinical Hospital for Children — Bucharest,
• Fundeni Clinical Institute - Constantinesco — Bucharest,
• Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology — Craiova,
• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do
• Kyungpook National University — Daegu,
• Asan Medical Center — Seoul,
• Samsung Medical Center — Seoul,
• Severance Children's Hospital — Seoul,
• National Taiwan University Hospital — Taipei,
• Taipei Veterans General Hospital — Taipei,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Hepatitis B

• Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection — Los Angeles, California
• VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B — Bethesda, Maryland
• Intrahepatic and Peripheral Responses to Imdusiran (AB-729) in Chronic Hepatitis B — Baltimore, Maryland
• Adaptability of an Undetectable = Untransmissible Model for HBV — New York, New York

Explore by condition: All Chronic Hepatitis B clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.