Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
NCT ID: NCT02932150
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2016-11-30
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAF (Cohort 1)
Participants (12 to \< 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks
TAF
Administered orally once daily
Placebo (Cohort 1)
Participants (12 to \< 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks
Placebo
Administered orally once daily
TAF (Cohort 2 Group 1)
Participants (6 to \< 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks
TAF
Administered orally once daily
TAF (Cohort 2 Group 2)
Participants (6 to \< 12 years) weighing ≥ 14 kg to \< 25 kg will receive TAF 15 mg oral granules for 24 weeks
TAF
Administered orally once daily
TAF (Cohort 2 Group 3)
Participants (2 to \< 6 years) will receive TAF for 24 weeks as follows:
* weight ≥ 10 kg to \< 14 kg (7.5 mg oral granules)
* weight ≥ 14 kg to \< 25 kg (15 mg oral granules)
TAF
Administered orally once daily
Cohort 2 Placebo
Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.
Placebo
Administered orally once daily
Open-Label TAF
Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.
TAF
Administered orally once daily
Interventions
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TAF
Administered orally once daily
Placebo
Administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* Weight at screening as follows:
* Cohort 1 = ≥ 35 kg (≥ 77 lbs)
* Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs)
* Cohort 2 Group 2 = ≥ 14 kg to \< 25 kg (≥ 30 lbs to \<55 lbs)
* Cohort 2 Group 3 = ≥ 10 kg to \< 14 kg (≥ 22 lbs to \< 30 lbs) or
* 14 kg to \< 25 kg (≥ 30 lbs to \< 55 lbs)
* Willing and able to provide written informed consent/assent (child and parent/legal guardian)
* Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months)
* HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
* Screening HBV DNA ≥ 2 × 10\^4 IU/mL
* Screening serum ALT \> 45 U/L (\> 1.5 × ULN: 30 U/L) and ≤ 10 × ULN (by central laboratory range)
* Treatment-naive or treatment-experienced will be eligible for enrollment.
* Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m\^2 (using the Schwartz formula)
* Normal ECG
Exclusion Criteria
* Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study.
* Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
* Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is \< 50 ng/mL no imaging study is needed; however, if the screening AFP is \> 50 ng/mL an imaging study is required)
* Any history of, or current evidence of, clinical hepatic decompensation
* Abnormal hematological and biochemical parameters
* Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
* Received solid organ or bone marrow transplant
* Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants
* Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
* Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible.
* Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance.
2 Years
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Rady Childrens Hospital
San Diego, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital - Main Hospital
Houston, Texas, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Cliniques Universitaires Saint-LUC UCL
Brussels, , Belgium
Prince of Wales Hospital
Shatin, , Hong Kong
Institute of Post Graduation Medical Education & Research
Kolkata, , India
M. V Hospital and Research Center
Lucknow, , India
Seth GS Medical College and KEM Hospital
Mumbai, , India
LTMMC & LTMG Hospital
Mumbai, , India
Khalatkar Hospital
Nagpur, , India
All India Institute of Medical Sciences
New Delhi, , India
SIDS Hospital and Research Centre
Surat, , India
Samvedna Hospital
Varanasi, , India
Spitalul Grigore Alexandrescu-Sectia Pediatrie III
Bucharest, , Romania
Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"
Bucharest, , Romania
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, , Russia
Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases
Saint Petersburg, , Russia
Republican Clinical Hospital of Infectious Diseases named after A.F. Agafonov
Tatarstan, , Russia
Limited Medical Company Hepatolog
Tolyatti, , Russia
Kyungpook National University Hospital
Daegu, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2016-000785-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506143-42
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-320-1092
Identifier Type: -
Identifier Source: org_study_id
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