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Antisense Oligonucleotide

SOC NrtI for Chronic Hepatitis B

Phase 2
Waitlist Available
Research Sponsored by Assembly Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
Awards & highlights

Study Summary

This trial will test if VBR + AB-729 is safe and effective in people with chronic hepatitis B infection receiving a standard nucleos(t)ide/reverse transcriptase inhibitor.

Eligible Conditions
  • Chronic Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With One or More Abnormal Laboratory Result
Number of Participants With One or More Adverse Events (AEs)
Number of Participants With Premature Treatment Discontinuation Due to AEs
Secondary outcome measures
Change From Baseline in Mean log10 HBV RNA Off-Treatment
Change From Baseline in Mean log10 HBV RNA On-Treatment
Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: VBR + SOC NrtIExperimental Treatment2 Interventions
Participants with cHBV received VBR + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen.
Group II: VBR + AB-729 + SOC NrtIExperimental Treatment3 Interventions
Participants with cHBV received VBR + AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up.
Group III: AB-729 + SOC NrtIExperimental Treatment2 Interventions
Participants with cHBV received AB-729 + SOC NrtI for 48 weeks followed by 48 weeks in follow-up. This treatment was used as a reference regimen.

Find a Location

Who is running the clinical trial?

Assembly BiosciencesLead Sponsor
18 Previous Clinical Trials
1,055 Total Patients Enrolled
Arbutus Biopharma CorporationIndustry Sponsor
12 Previous Clinical Trials
607 Total Patients Enrolled
~16 spots leftby Jun 2025
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