NCT03125213

A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	AL-3778	AL-3778 tablets
DRUG	Peginterferon Alfa-2A	Peginterferon Alfa-2A for subcutaneous injection
DRUG	Placebo Oral Tablet	Placebo to Match AL-3778 tablet

Timeline

• Start date: 2017-09-12
• Primary completion: 2019-02-15
• Completion: 2019-02-15
• First posted: 2017-04-24
• Last updated: 2017-10-16

Regulatory

• FDA-regulated drug study