The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.
Eligibility
Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Key Inclusion criteria:
* Males and non-pregnant, non-lactating females
* 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
Key Exclusion criteria:
* Females who are pregnant or breastfeeding
* 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) at Week 24 — Week 24
Incidence of Treatment-Emergent Adverse Events (AEs) at Week 24 — Week 24
Percentage of participants with plasma HBV DNA < 20 IU/mL at Week 24 — Week 24
PK Parameter: AUCtau of TAF for participants from Cohort 2 Part A — Predose, 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours postdose at Week 4 or 8 or 12 AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Trial sites (39)
Facility
City
Region
Status
Children's Hospital of Los Angeles
Los Angeles
California
Rady Childrens Hospital
San Diego
California
University of California, San Francisco (UCSF)
San Francisco
California
Children's Hospital Colorado
Aurora
Colorado
Indiana University School of Medicine
Indianapolis
Indiana
Johns Hopkins University
Baltimore
Maryland
Children's Mercy Hospital
Kansas City
Missouri
The Children's Hospital at Montefiore
The Bronx
New York
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Nationwide Children's Hospital
Columbus
Ohio
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville
Tennessee
Cook Children's Medical Center
Fort Worth
Texas
Texas Children's Hospital - Main Hospital
Houston
Texas
American Research Corporation at Texas Liver Institute
San Antonio
Texas
Seattle Children's Hospital
Seattle
Washington
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
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.
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