Chronic Hepatitis b
Conditions
Keywords
Hepatitis B virus, Chronic hepatitis B, HBV, Hepatitis, CHB
Brief summary
This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
Interventions
DRUGAB-729
subcutaneous injection
DRUGPeg-IFNα-2a
subcutaneous injection
Sponsors
Arbutus Biopharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis B virus infection with documentation at least 6 months prior to screening * Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1 * HBV DNA \<LLOQ at Screening * HBsAg between 100 and 5,000 IU/mL at Screening * Subjects must be HBeAg-negative at Screening * Fibroscan® result of ≤8.5 kPa within 6 months prior to dosing Day 1 * Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Exclusion criteria
* Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening * 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 * Contraindications to the use of Peg-IFNα-2a or incapable of self-administration or assisted administration of Peg-IFNα-2a * Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Up to 124 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with HBsAb seroconversion at each timepoint | Up to 124 weeks |
| Proportion of subjects who are eligible to stop NA after Week 24 of follow up | Up to 76 weeks |
| Change from baseline in HBsAg and other virologic markers at each time point | Up to 124 weeks |
| Proportion of subjects who discontinue NA and subsequently meet protocol defined clinical relapse criteria. Proportion of subjects who discontinue NA and subsequently meet protocol defined viral relapse criteria | Up to 124 weeks |
| 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 | Up to 40 weeks |
| Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria | Up to 124 weeks |
Countries
Australia, Hong Kong, Moldova, South Korea, Taiwan, Ukraine, United States
Outcome results
None listed