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A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
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)
Details
| Lead sponsor | Alios Biopharma Inc. |
|---|---|
| Phase | PHASE2 |
| Status | WITHDRAWN |
| Start date | Tue Sep 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Feb 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Hepatitis B, Chronic
Interventions
- AL-3778
- Peginterferon Alfa-2A
- Placebo Oral Tablet