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Interferon
VIR-2218 + VIR-3434 + PEG-IFNα for Chronic Hepatitis B (MARCH Trial)
Verified Trial
Phase 2
Waitlist Available
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Chronic Hepatitis B
Have you been diagnosed with chronic hepatitis B virus infection for at least 6 months?
Must not have
Have you taken any interferon-containing therapy (for example, Pegasys or Peg-Intron) within the past 12 months?
Have you had major surgery within the past 3 months?
Timeline
Screening 60 days
Treatment 24 weeks
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical reactions related to immune system activation such as flu-like symptoms from PEG-IFNα; infusion-related reactions; possible organ inflammation due to antibody treatment; fatigue; and allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 60 days0 visits
Treatment ~ 24 weeks0 visits
Follow Up ~ 48 weeks0 visits
Screening ~ 60 days
Treatment ~ 24 weeks
Follow Up ~48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~290
VIR-3434
2020
Completed Phase 1
~120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Hepatitis B include RNA interference, monoclonal antibodies, and immune system boosters. RNA interference, such as with VIR-2218, targets and degrades HBV mRNA, reducing the production of viral proteins and replication of the virus.
Monoclonal antibodies like VIR-3434 target HBV surface antigens, neutralizing the virus and preventing it from infecting new cells. PEG-IFNα boosts the immune system, enhancing the body's ability to fight off the virus.
These treatments are crucial for Chronic Hepatitis B patients as they aim to reduce viral load, prevent liver damage, and improve long-term health outcomes.
Find a Location
Who is running the clinical trial?
Vir Biotechnology, Inc.Lead Sponsor
29 Previous Clinical Trials
13,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on NRTI therapy for at least 2 months.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
- Group 2: Cohort 1d (VIR-3434 + PEG-IFNα)
- Group 3: Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
- Group 4: Cohort 4a (VIR-2218 + VIR-3434)
- Group 5: Cohort 3a (VIR-2218 + VIR-3434)
- Group 6: Cohort 5a (VIR-2218 + VIR-3434)
- Group 7: Cohort 2b (VIR-3434)
- Group 8: Cohort 6a (VIR-2218 + VIR-3434)
- Group 9: Cohort 7a (VIR-2218 + VIR-3434)
- Group 10: Cohort 8a (VIR-2218 + VIR-3434)
- Group 11: Cohort 1b (VIR-3434)
- Group 12: Cohort 1a (VIR-2218 + VIR-3434)
- Group 13: Cohort 2a (VIR-2218 + VIR-3434)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 60 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 24 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 48 Weeks after you stop receiving the treatment.