Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B Infection
Intervention: Tenofovir DF (Drug); Placebo to match TDF (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): John Flaherty, PharmD, Study Director, Affiliation: Gilead Sciences
Overall contact: Gilead Study Team, Email: 174-0144@gilead.com
Summary
This placebo-controlled study evaluates the efficacy, safety and tolerability of tenofovir
disoproxil fumarate (TDF) in participants 2 to < 12 years old with chronic Hepatitis B
infection. While studies have shown significant virologic response in adults and
adolescents, the effect in children is not well established. This study will provide
valuable data that can help establish the efficacy and safety profiles of TDF in children.
The study will consist of 72 weeks of blinded randomized treatment, after which participants
will switch to open-label TDF treatment for an additional 120 weeks.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of participants with serum HBV DNA < 400 copies/mL at week 72
Secondary outcome: Proportion of participants with hepatitis B e antigen (HBeAg) seroconversion at Week 72Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine Percent change from baseline in bone mineral density of lumbar spine Proportion of participants with normal ALT and normalization of ALT Composite endpoint of proportion of participants with HBV DNA < 400 copies/mL and normal ALT Genotypic changes from baseline within the HBV polymerase for patients who were viremic (HBV DNA > or equal 400 copies/mL) with confirmed virologic breakthrough Proportion of participants with HBV DNA < 169 copies/mL Proportion of participants with HBsAg loss and seroconversion
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or Female, 2 to < 12 years of age
- Weight ≥ 10kg
- Chronic HBV infection ≥ 6 months
- HBeAg-positive or HBeAg-negative
- HBV Viral Load ≥ 100,000 copies/mL
- Alanin aminotransferase (ALT) ≥ 1. 5 x the upper limit of the normal range (ULN) at
screening
- Creatinine Clearance ≥ 80 mL/min
- Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10g/dL
- Negative pregnancy test at screening
- No prior tenofovir DF therapy (subjects may have received prior interferon‑alfa
and/or other oral anti‑HBV nucleoside/nucleotide therapy; subjects must have
discontinued interferon-alfa therapy ≥ 6 months prior to screening; subjects
experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued
therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo
arm)
Exclusion Criteria:
- Pregnant or lactating
- Decompensated liver disease
- Received interferon therapy within 6 months of Screening
- Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of Screening
- Alpha-fetoprotein levels > 50 ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HIV, acute hepatitis A virus (HAV), hepatitis C virus (HCV), or
hepatitis D virus (HDV)
- Chronic liver disease not due to HBV
- History of significant renal, cardiovascular, pulmonary, neurological or bone disease
- Long term non-steroidal, anti-inflammatory drug therapy
Locations and Contacts
Gilead Study Team, Email: 174-0144@gilead.com
Dr. Georgi Stranski Multiprofile Hospital for Active Treatment, Pleven 5800, Bulgaria; Withdrawn
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plodiv 4002, Bulgaria; Recruiting
Multiprofile Hospital for Active Treatment "Tokuda Hospital", Sofia 1407, Bulgaria; Recruiting
Nirmal Hospital Private Limited, Gujarat 395 002, India; Recruiting
Indraprastha Apollo Hospitals, New Delhi 110076, India; Recruiting
SMS Medical College and Hospital, Rajasthan 302004, India; Recruiting
Kyungpook National University, Daegu 700-721, Korea, Republic of; Recruiting
Gachon University Gil Hospital, Department of Pediatrics, Incheon 405-760, Korea, Republic of; Withdrawn
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting
Severance Children's Hospital, Seoul 120-752, Korea, Republic of; Recruiting
Pusan National University Yangsan Hospital, Yangsan-si 626 770, Korea, Republic of; Recruiting
ID Clinic, Myslowice 41-400, Poland; Withdrawn
Fundeni Clinical Institute - Constantinesco, Bucharest 022328, Romania; Recruiting
Grigore Alexandrescu Emergency Clinical Hospital for Children, Bucharest 011743, Romania; Active, not recruiting
National Institute of Infectious Diseases, Bucharest 021105, Romania; Withdrawn
Clinical Infectious Diseases Hospital of Constanta, Constanta 900708, Romania; Withdrawn
"Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisology, Craiova 200515, Romania; Recruiting
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Taipei Veterans General Hospital, Taipei 11217, Taiwan; Recruiting
Gandhi Hospital and Medical College, Secunderabad, Andhra Pradesh 500-033, India; Recruiting
King George Hospital, Visakhapatnam, Andhra Prasad 530 002, India; Recruiting
Phoenix Children's Hospital, Phoenix, Arizona 85016, United States; Recruiting
University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
University of Colorado School of Medicine, Aurora, Colorado 80045, United States; Recruiting
Medanta -The Medicity, Gurgaon, Haryana 122 001, India; Recruiting
Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India; Recruiting
Colors Children Hospital, Nagpur, Maharashtra 440012, India; Recruiting
New York School of Medicine, New York, New York 10016, United States; Recruiting
Sparsh Hospital, Bhubaneswar, Odhisa Andaman and Nicobar Islands 751007, India; Recruiting
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting
M.V. Hospital and Research Centre 314/30 Mirza Mandi Chowk, Lucknow, Uttar Pradesh 226003, India; Recruiting
Additional Information
Starting date: December 2012
Last updated: August 18, 2015
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