VIR-2218 + VIR-3434 + PEG-IFNα for Chronic Hepatitis B
(MARCH Trial)
Recruiting in Palo Alto (17 mi)
+32 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Vir Biotechnology, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial involves testing three treatments (VIR-2218, VIR-3434, and PEG-IFNα) on patients with chronic hepatitis B. The goal is to see if these treatments are safe, can be tolerated by patients, and are effective in reducing the virus. The treatments work by either lowering the virus levels or boosting the immune system to fight the virus. Peginterferon alpha (PEG-IFNα) has been used to treat chronic hepatitis B by modulating the immune system, often in combination with other medications for enhanced efficacy.
Eligibility Criteria
This trial is for men and women aged 18 to 65 with chronic hepatitis B infection lasting at least 6 months, who have been on NRTI therapy for over two months. It's not suitable for those with significant liver damage, history of severe allergic reactions to monoclonal antibodies or interferons, other chronic liver diseases, substance abuse issues, or certain medical conditions.Inclusion Criteria
You have been diagnosed with Chronic Hepatitis B
Have you been diagnosed with chronic hepatitis B virus infection for at least 6 months?
Have been on stable nucleoside/nucleotide analogue (NA) treatment (for example, tenofovir or entecavir) for the last 6 months?
Exclusion Criteria
Have you had major surgery within the past 3 months?
Have you taken any interferon-containing therapy (for example, Pegasys or Peg-Intron) within the past 12 months?
You have been diagnosed with Liver Disease
+7 more
Participant Groups
The study tests the safety and effectiveness of VIR-2218, VIR-3434, and/or PEG-IFNα in treating chronic hepatitis B. Participants will receive one or more of these treatments as part of a phase 2 clinical trial designed to evaluate how well they work and how safe they are.
13Treatment groups
Experimental Treatment
Group I: Cohort 8a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Group II: Cohort 7a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Group III: Cohort 6a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Group IV: Cohort 5a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Group V: Cohort 4a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Group VI: Cohort 3a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Group VII: Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)Experimental Treatment3 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Group VIII: Cohort 2b (VIR-3434)Experimental Treatment1 Intervention
Participants will receive multiple doses of VIR-3434 for 20 weeks
Group IX: Cohort 2a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Group X: Cohort 1d (VIR-3434 + PEG-IFNα)Experimental Treatment2 Interventions
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
Group XI: Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)Experimental Treatment3 Interventions
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Group XII: Cohort 1b (VIR-3434)Experimental Treatment1 Intervention
Participants will receive multiple doses of VIR-3434 for 44 weeks
Group XIII: Cohort 1a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Investigative SiteSan Francisco, CA
Investigative SiteOrlando, FL
Investigative SiteHillsborough, NJ
Investigative SiteVancouver, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.Lead Sponsor