Last updated on August 2018

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


Brief description of study

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 adolescent 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.

Clinical Study Identifier: NCT02932150

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San Francisco, CA United States
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Miami, FL United States
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Indianapolis, IN United States
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Morgantown, WV United States
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Daegu, Korea, Republic of
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Seoul, Korea, Republic of
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Kazan, Russian Federation
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Krasnoyarsk, Russian Federation
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Moscow, Russian Federation
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Saint Petersburg, Russian Federation
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Tolyatti, Russian Federation
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Aurora, CO United States
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Kansas City, MO United States
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Cincinnati, OH United States
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Nashville, TN United States
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Dallas, TX United States
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Los Angeles, CA United States
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