AB-729 + Pegylated Interferon for Chronic Hepatitis B

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Arbutus Biopharma Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called AB-729 for patients with Chronic Hepatitis B. It is used along with existing treatments to lower virus levels, manage the virus, and boost the immune system.

Eligibility Criteria

This trial is for adults with chronic hepatitis B who've been on specific antiviral drugs for at least a year, have low HBV DNA levels, are HBeAg-negative, and have liver scarring within safe limits. It's not open to those with other viral infections like HIV or conditions suggesting advanced liver disease.

Inclusion Criteria

I have been on TAF, TDF, or ETV for at least 12 months.

My recent health checks show no major concerns.

Chronic hepatitis B virus infection with documentation at least 6 months prior to screening

+4 more

Exclusion Criteria

I have been treated with experimental HBV drugs.

I have a history of serious liver disease or signs of liver cancer.

Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening

+1 more

Participant Groups

The study tests the safety and virus-fighting ability of AB-729 combined with ongoing antiviral therapy and short courses of Peg-IFNα-2a in people with chronic hepatitis B. Participants will be chosen randomly to receive this combination treatment.

4Treatment groups

Experimental Treatment

Group I: Cohort B, Group 2Experimental Treatment2 Interventions

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Group II: Cohort B, Group 1Experimental Treatment2 Interventions

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Group III: Cohort A, Group 2Experimental Treatment2 Interventions

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Group IV: Cohort A, Group 1Experimental Treatment2 Interventions

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.