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A study to understand the safety and effectiveness of a new drug called TAF for the treatment of long term hepatitis B infection in adolescents

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-000785-37

Femme et Homme

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Extrait

Part A: -To evaluate the steady state pharmacokinetics (PK) of tenofovir alafenamide (TAF) and confirm the dose of TAF 25 mg tablet given once daily in treatment-naïve and treatment-experienced adolescent subjects (aged 12 to < 18 years) with chronic hepatitis B (CHB). Part B: To evaluate the safety, tolerability, and antiviral activity (HBV DNA < 20 IU/mL) of TAF 25 mg once daily versus placebo through Week 24 in treatment-naive and treatment-experienced adolescent subjects with CHB

Critère d'inclusion

  • Chronic hepatitis B

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