Tenofovir Alafenamide (TAF) in Children and Adolescents With Chronic Hepatitis B Virus Infection



Status:Recruiting
Conditions:Infectious Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 17
Updated:3/15/2019
Start Date:November 2016
End Date:November 2026
Contact:Gilead Study Team
Email:GS-US-320-1092@gilead.com

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A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects With Chronic Hepatitis B Virus Infection

The primary objective of Cohort 1 of this study is to evaluate the safety, tolerability, and
antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily
versus placebo through Week 24 in treatment-naive and treatment-experienced adolescents (aged
12 to < 18 years) with chronic hepatitis B (CHB).

Cohort 2 will consist of 2 parts: Part A and Part B. Intensive pharmacokinetic (PK) data will
be collected from all participants in Part A to confirm the dose of TAF in each dose group
and the remaining participants will be enrolled into Part B once dose confirmation is
achieved. The primary objectives of Part A are to evaluate the steady-state PK of TAF and
tenofovir (TFV) and confirm the dose of TAF given once daily in children (aged 2 to < 12
years) with CHB. The primary objective of Part B is to evaluate the safety and tolerability
of TAF at Week 48 and the antiviral activity (HBV DNA < 20 IU/mL) of TAF at Week 24 in
children (aged 2 to < 12 years) with CHB.


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 = ≥ 17 kg to < 25 kg (≥ 37 lbs to <55 lbs)

- Cohort 2 Group 3 = < 17 kg (< 37 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)

- 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 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.
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