Study of efficacy and safety, tolerability and pharmacokinetics of telbivudine in children and adolescents with compensated chronic hepatitis B virus infection

Update Il y a 4 ans
Reference: EUCTR2012-004942-14

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Extract

The primary objective of this study is to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL at Week 24.


Inclusion criteria

  • compensated HBeAg-positive and negative chronic hepatitis B virus infection