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Interferon
VIR-2218 + VIR-3434 + PEG-IFNα for Chronic Hepatitis B (MARCH Trial)
Verified Trial
Phase 2
Recruiting
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
MARCH Trial 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.
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.Check my eligibility
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.See study design
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.
MARCH Trial 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:MARCH Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with HBsAg loss at 24 weeks post-end of treatment
Proportion of subjects with HBsAg loss at end of treatment
Proportion of subjects with serious adverse events (SAEs)
+1 moreSecondary outcome measures
%AUCexp
AUCinf
AUClast
+20 moreMARCH Trial Design
12Treatment groups
Experimental Treatment
Group I: Cohort 8a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Group II: Cohort 7a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Group III: Cohort 6a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Group IV: Cohort 5a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Group V: Cohort 4a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Group VI: Cohort 3a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Group VII: Cohort 2c (VIR-2218 + VIR-3434)Experimental Treatment3 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Group VIII: Cohort 2b (VIR-3434)Experimental Treatment1 Intervention
Subjects will receive multiple doses of VIR-3434 for 20 weeks
Group IX: Cohort 2a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Group X: Cohort 1c (VIR-2218 + VIR-3434)Experimental Treatment3 Interventions
Subjects will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Group XI: Cohort 1b (VIR-3434)Experimental Treatment1 Intervention
Subjects will receive multiple doses of VIR-3434 for 44 weeks
Group XII: Cohort 1a (VIR-2218 + VIR-3434)Experimental Treatment2 Interventions
Subjects 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-3434
2020
Completed Phase 1
~120
VIR-2218
2020
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
12,998 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)
- Group 2: Cohort 4a (VIR-2218 + VIR-3434)
- Group 3: Cohort 3a (VIR-2218 + VIR-3434)
- Group 4: Cohort 5a (VIR-2218 + VIR-3434)
- Group 5: Cohort 2b (VIR-3434)
- Group 6: Cohort 6a (VIR-2218 + VIR-3434)
- Group 7: Cohort 7a (VIR-2218 + VIR-3434)
- Group 8: Cohort 8a (VIR-2218 + VIR-3434)
- Group 9: Cohort 1b (VIR-3434)
- Group 10: Cohort 2c (VIR-2218 + VIR-3434)
- Group 11: Cohort 1a (VIR-2218 + VIR-3434)
- Group 12: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is this trial currently recruiting?
"Affirmative. Per information on clinicaltrials.gov, this research is still seeking volunteers since it was first posted in July 2021 and most recently edited in October 2022. 260 participants are desired from 7 distinct locations."
Answered by AI
Am I eligible to join the research endeavor?
"To qualify for this medical trial, individuals must have chronic hepatitis b and be between 18 to 65 years old. Approximately 260 participants are being accepted into the study."
Answered by AI
Are there any restrictions regarding the age of participants in this experiment?
"The necessary requirements for participation in this trial fall within the boundaries of 18 to 65 years old. Conversely, there are 72 clinical trails tailored towards those under 18 and 304 trials designed specifically for patients over 65."
Answered by AI
Is this research project currently accepting volunteers?
"Affirmative. According to clinicaltrials.gov, this medical study has been live since July 11th 2021 and is still recruiting participants. Altogether 260 individuals need to be enrolled from 7 respective sites for completion of the trial."
Answered by AI
In how many venues is this experiment taking place?
"This medical trial is recruiting from 7 distinct locales, including Orlando, Vancouver and San Francisco. It is prudent to choose the clinic nearest you so your travel needs are minimized when signing up for this study."
Answered by AI
What risks do individuals face when exposed to Cohort 2c (VIR-2218 + VIR-3434)?
"The safety profile of Cohort 2c (VIR-2218 + VIR-3434) was given a rating of 2 due to its Phase 2 status, meaning that while some data exists in regards to the drug's safety, no evidence currently supports its efficacy."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Investigative Site
How responsive is this trial?
Most responsive sites:
- Investigative Site: < 24 hours
Typically responds via
Phone Call
Average response time
- < 1 Day
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