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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
No Placebo-Only Group
Summary
This trial tests two new drugs, vebicorvir and AB-729, along with a standard treatment for chronic hepatitis B. It aims to see if this combination is safer and more effective. The drugs work by stopping the virus from multiplying and reducing viral proteins.
Eligible Conditions
- Chronic Hepatitis B
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change From Baseline in Mean log10 HBV RNA On-Treatment
Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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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
577 Total Patients Enrolled
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