← Back to Search

Nucleos(t)ide Analogue

AB-729 + Pegylated Interferon for Chronic Hepatitis B

Phase 2
Waitlist Available
Research Sponsored by Arbutus Biopharma Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1
Be between 18 and 65 years old
Must not have
Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product
History of any clinically significant medical condition associated with chronic liver disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of hepatocellular carcinoma (HCC) at any time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 124 weeks
Awards & highlights

Summary

This trial is testing a new drug to treat hepatitis B. The drug is being given with other drugs that are used to treat hepatitis B. The trial is testing how safe and effective the new drug is.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include flu-like symptoms, fatigue, headache, fever from Peg-IFNα-2a; AB-729's side effects aren't fully known but could involve reactions at the injection site or changes in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on TAF, TDF, or ETV for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with experimental HBV drugs.
Select...
I have a history of serious liver disease or signs of liver cancer.
Select...
I cannot use or self-administer Peg-IFNα-2a due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 124 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 124 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities after dosing with AB-729 plus Peg-IFNα-2a
Secondary outcome measures
Change from baseline in HBsAg and other virologic markers at each time point
Post-dose plasma concentrations of AB-729 anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at selected timepoints
Proportion of subjects who are eligible to stop NA after Week 24 of follow up
+3 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Hepatitis B (CHB) include nucleos(t)ide analogs and RNA interference (RNAi) therapeutics. Nucleos(t)ide analogs, such as tenofovir and entecavir, inhibit the reverse transcriptase enzyme, essential for HBV DNA replication, thereby reducing viral load and liver damage. RNAi therapeutics, like AB-729, target HBV genes by degrading viral RNA, preventing the production of viral proteins and replication. These mechanisms are crucial for CHB patients as they help lower viral load, limit liver damage, and improve long-term health outcomes.

Find a Location

Who is running the clinical trial?

Arbutus Biopharma CorporationLead Sponsor
12 Previous Clinical Trials
629 Total Patients Enrolled

Media Library

AB-729 (Nucleos(t)ide Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT04980482 — Phase 2
Chronic Hepatitis B Research Study Groups: Cohort B, Group 2, Cohort A, Group 1, Cohort A, Group 2, Cohort B, Group 1
Chronic Hepatitis B Clinical Trial 2023: AB-729 Highlights & Side Effects. Trial Name: NCT04980482 — Phase 2
AB-729 (Nucleos(t)ide Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980482 — Phase 2
~12 spots leftby Jul 2025