Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection (MARCH)

September 22, 2023 updated by: Vir Biotechnology, Inc.

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects may be enrolled into cohorts 1a, 2a, 3a, 4a, 5a, 6a, 1b, and 2b in a non-randomized manner. Subjects may be enrolled in cohorts 7a, 8a, 1c, and 2c and will be randomized.

Study Type

Interventional

Enrollment (Estimated)

415

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Toronto, Canada, 2C4
        • Recruiting
        • Investigative Site
      • Toronto, Canada, 3M1
        • Recruiting
        • Investigative Site
      • Vancouver, Canada, 2C7
        • Recruiting
        • Investigative Site
  • Germany
      • Frankfurt, Germany, 60590
        • Recruiting
        • Investigative Site
      • Hannover, Germany, 30625
        • Recruiting
        • Investigative Site
      • Mannheim, Germany, 68167
        • Recruiting
        • Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Investigative Site
    • Shatin
      • Hong Kong, Shatin, Hong Kong
        • Recruiting
        • Investigative Site
    • Tai Po
      • Hong Kong, Tai Po, Hong Kong
        • Recruiting
        • Investigative Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49421
        • Recruiting
        • Investigative Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Investigative Site
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Investigative Site
      • Yangsan, Korea, Republic of, 50612
        • Recruiting
        • Investigative Site
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Recruiting
        • Investigative Site
      • Kajang, Malaysia, 43000
        • Recruiting
        • Investigative Site
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Investigative Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD 2025
        • Recruiting
        • Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1010
        • Recruiting
        • Investigative Site
      • Auckland, New Zealand, 2025
        • Recruiting
        • Investigative Site
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Investigative Site
      • Tauranga, New Zealand, 3110
        • Recruiting
        • Investigative Site
      • Wellington, New Zealand, 6021
        • Recruiting
        • Investigative Site
  • Romania
      • Bucharest, Romania, 021105
        • Recruiting
        • Investigative Site
  • Taiwan
      • Chiayi City, Taiwan, 60041
        • Recruiting
        • Investigative Site
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Investigative Site
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Investigative Site
      • Taichung City, Taiwan, 40705
        • Recruiting
        • Investigative Site
      • Taipei City, Taiwan, 100
        • Recruiting
        • Investigative Site
      • Taoyuan City, Taiwan, 33305
        • Recruiting
        • Investigative Site
  • Ukraine
      • Kyiv, Ukraine, 01135
        • Recruiting
        • Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Investigative Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Investigative Site
      • London, United Kingdom, E11FR
        • Recruiting
        • Investigative Site
      • Manchester, United Kingdom, M8 5RB
        • Recruiting
        • Investigative Site
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • Investigative Site
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Investigative Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Investigative Site
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Recruiting
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female ages 18 - <66 years
  • Chronic HBV infection for >/= 6 months
  • On NRTI therapy for >/= 2 months at the time of screening

Exclusion Criteria:

  • Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
  • Significant fibrosis or cirrhosis
  • History or evidence of drug or alcohol abuse
  • History of chronic liver disease from any cause other than chronic HBV infection
  • History of hepatic decompensation
  • History of anaphylaxis
  • History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
  • History of immune complex disease
  • History of known contraindication to any interferon product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 2a (VIR-2218 + VIR-3434)
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 3a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 4a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 5a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 6a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 7a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 8a (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 1b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 44 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 2b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 20 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection
Experimental: Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection
Experimental: Cohort 1d (VIR-2218 + PEG-IFNα)
Participants will receive multiple doses of VIR-2218 + PEG-IFNα for 48 weeks
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection
Experimental: Cohort 2d (VIR-3434 + PEG-IFNα)
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Drug: PEG-IFNα
PEG-IFNα given by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants with serious adverse events (SAEs)
Time Frame: Up to 116 weeks
Up to 116 weeks
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Time Frame: Up to 48 weeks
Up to 48 weeks
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
Time Frame: Up to 72 weeks
Up to 72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute serum HBsAg and change from baseline across all timepoints in the study
Time Frame: Up to 110 weeks
Up to 110 weeks
Nadir and maximum reduction of serum HBsAg from baseline
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
Time Frame: Up to 110 weeks
Up to 110 weeks
For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Time Frame: Up to 110 weeks
Up to 110 weeks
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Time Frame: Up to 110 weeks
Up to 110 weeks
Cmax
Time Frame: Up to 110 weeks
Up to 110 weeks
Clast
Time Frame: Up to 110 weeks
Up to 110 weeks
Tmax
Time Frame: Up to 110 weeks
Up to 110 weeks
Tlast
Time Frame: Up to 110 weeks
Up to 110 weeks
AUCinf
Time Frame: Up to 110 weeks
Up to 110 weeks
AUClast
Time Frame: Up to 110 weeks
Up to 110 weeks
%AUCexp
Time Frame: Up to 110 weeks
Up to 110 weeks
t1/2
Time Frame: Up to 110 weeks
Up to 110 weeks
λz
Time Frame: Up to 110 weeks
Up to 110 weeks
Vz/F
Time Frame: Up to 110 weeks
Up to 110 weeks
CL/F
Time Frame: Up to 110 weeks
Up to 110 weeks
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Time Frame: Up to 60 weeks
Up to 60 weeks
Proportion of participants meeting criteria for NRTI retreatment
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs
Time Frame: Up to 110 weeks
Up to 110 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Time Frame: Up to 48 weeks
Up to 48 weeks
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Time Frame: Up to 72 weeks
48 weeks treatment + 24 weeks post-end of treatment
Up to 72 weeks
Proportion of participants with anti-HBs seroconversion
Time Frame: Up to 110 weeks
Up to 110 weeks
Time to achieve nadir of serum HBsAg
Time Frame: Up to 110 weeks
Up to 110 weeks
Time to achieve serum HBsAg loss
Time Frame: Up to 110 weeks
Up to 110 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vir Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-2218-1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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