Hepatitis B, Chronic Clinical Trial
Official title:
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of AL-3778 in Combination With Peginterferon Alpha-2a in Treatment Naïve Chronic Hepatitis B Subjects Who Are HBeAg-positive
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study
evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with
Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are
treatment-naïve.
The study will consist of a screening phase , a double-blind treatment phase followed by
treatment with Peg-IFN alone, and a post-treatment follow-up phase.
Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2
treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:
- Arm A: Peg-IFN plus AL-3778 (N=20)
- Arm B: Peg-IFN plus matching placebo (N=10)
n/a
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