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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 6, 2012

Primary Completion Date

August 7, 2017

Study Completion Date

July 31, 2027

Conditions
Chronic Hepatitis B
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."

Trial Locations (21)

100

National Taiwan University Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

41944

Kyungpook National University, Daegu

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

50612

Pusan National University Yangsan Hospital, Yangsan

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

85016

Phoenix Children's Hospital, Phoenix

94143

University of California, San Francisco, San Francisco

200515

Victor Babes Clinical Hospital of Infectious Diseases and Pneumophtisology, Craiova

226003

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

302004

SMS Medical College and Hospital, Jaipur

440012

Colors Children Hospital, Nagpur

560034

St. John Hospital & Medical Center, Bangalore

395 002

Nirmal Hospital Private Limited, Surat

122 001

Medanta -The Medicity, Gurgaon

011743

Grigore Alexandrescu Emergency Clinical Hospital for Children, Bucharest

022328

Fundeni Clinical Institute - Constantinesco, Bucharest

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

120-752

Severance Children's Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY