Cohort 2c (VIR-2218 + VIR-3434) for Hepatitis B, Chronic
Phase-Based Progress Estimates
Effectiveness
Safety
Hepatitis B, Chronic+6 More
VIR-2218 - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
This trial is testing new drugs to treat hepatitis B. The drugs will be given to people who have the virus and researchers will see how well they work, how safe they are, and how well they are tolerated.
Eligible Conditions
- Hepatitis B, Chronic
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 24 Secondary · Reporting Duration: Up to 116 weeks
Up to 110 weeks
Absolute serum HBsAg and change from baseline across all timepoints in the study
For HBeAg-positive subjects: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
For hepatitis B e-antigen (HBeAg)-positive subjects: Proportion of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Number of subjects with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Proportion of subjects achieving undetectable hepatitis B surface antigen (HBsAg) and sustained suppression of HBV DNA [target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Proportion of subjects meeting criteria for NRTI retreatment
Proportion of subjects with anti-HBs seroconversion
Proportion of subjects with serum HBsAg loss (defined as undetectable HBsAg)
Proportion of subjects with treatment-emergent adverse events (TEAEs)
Time to achieve the nadir and maximum reduction of serum HBsAg from baseline
Up to 116 weeks
Number of subjects with post-treatment lab abnormalities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Proportion of subjects with serious adverse events (SAEs)
Up to 48 weeks
Proportion of subjects with HBsAg loss at end of treatment
Hepatitis B Surface Antigens
Up to 60 weeks
Proportion of subjects meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Up to 64 weeks
%AUCexp
AUCinf
AUClast
CL/F
Clast
Cmax
Tlast
Tmax
Vz/F
t1/2
λz
Up to 72 weeks
Proportion of subjects with HBsAg loss at 24 weeks post-end of treatment
Proportion of subjects with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
12 Treatment Groups
Cohort 2c (VIR-2218 + VIR-3434)
1 of 12
Cohort 1a (VIR-2218 + VIR-3434)
1 of 12
Cohort 8a (VIR-2218 + VIR-3434)
1 of 12
Cohort 1b (VIR-3434)
1 of 12
Cohort 2a (VIR-2218 + VIR-3434)
1 of 12
Cohort 7a (VIR-2218 + VIR-3434)
1 of 12
Cohort 1c (VIR-2218 + VIR-3434)
1 of 12
Cohort 4a (VIR-2218 + VIR-3434)
1 of 12
Cohort 6a (VIR-2218 + VIR-3434)
1 of 12
Cohort 2b (VIR-3434)
1 of 12
Cohort 5a (VIR-2218 + VIR-3434)
1 of 12
Cohort 3a (VIR-2218 + VIR-3434)
1 of 12
Experimental Treatment
260 Total Participants · 12 Treatment Groups
Primary Treatment: Cohort 2c (VIR-2218 + VIR-3434) · No Placebo Group · Phase 2
Cohort 2c (VIR-2218 + VIR-3434)Experimental Group · 3 Interventions: VIR-2218, PEG-IFNα, VIR-3434 · Intervention Types: Drug, Drug, Drug
Cohort 1a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 8a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 1b (VIR-3434)
Drug
Experimental Group · 1 Intervention: VIR-3434 · Intervention Types: DrugCohort 2a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 7a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 1c (VIR-2218 + VIR-3434)Experimental Group · 3 Interventions: VIR-2218, PEG-IFNα, VIR-3434 · Intervention Types: Drug, Drug, Drug
Cohort 4a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 6a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 2b (VIR-3434)
Drug
Experimental Group · 1 Intervention: VIR-3434 · Intervention Types: DrugCohort 5a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Cohort 3a (VIR-2218 + VIR-3434)Experimental Group · 2 Interventions: VIR-2218, VIR-3434 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~110
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 116 weeks
Who is running the clinical trial?
Vir Biotechnology, Inc.Lead Sponsor
23 Previous Clinical Trials
12,670 Total Patients Enrolled
7 Trials studying Hepatitis B, Chronic
685 Patients Enrolled for Hepatitis B, Chronic
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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