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

Primary Purpose

Hepatitis B, Chronic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VIR-2218
VIR-3434
PEG-IFNα
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1a (VIR-2218 + VIR-3434)

Cohort 2a (VIR-2218 + VIR-3434)

Cohort 3a (VIR-2218 + VIR-3434)

Cohort 4a (VIR-2218 + VIR-3434)

Cohort 5a (VIR-2218 + VIR-3434)

Cohort 6a (VIR-2218 + VIR-3434)

Cohort 7a (VIR-2218 + VIR-3434)

Cohort 8a (VIR-2218 + VIR-3434)

Cohort 1b (VIR-3434)

Cohort 2b (VIR-3434)

Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)

Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)

Cohort 1d (VIR-2218 + PEG-IFNα)

Cohort 2d (VIR-3434 + PEG-IFNα)

Arm Description

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks

Participants will receive multiple doses of VIR-3434 for 44 weeks

Participants will receive multiple doses of VIR-3434 for 20 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks

Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks

Participants will receive multiple doses of VIR-2218 + PEG-IFNα for 48 weeks

Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks

Outcomes

Primary Outcome Measures

Proportion of participants with treatment-emergent adverse events (TEAEs)
Proportion of participants with serious adverse events (SAEs)
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment

Secondary Outcome Measures

Absolute serum HBsAg and change from baseline across all timepoints in the study
Nadir and maximum reduction of serum HBsAg from baseline
Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs)
For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Cmax
Clast
Tmax
Tlast
AUCinf
AUClast
%AUCexp
t1/2
λz
Vz/F
CL/F
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Proportion of participants meeting criteria for NRTI retreatment
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
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
48 weeks treatment + 24 weeks post-end of treatment
Proportion of participants with anti-HBs seroconversion
Time to achieve nadir of serum HBsAg
Time to achieve serum HBsAg loss

Full Information

First Posted
April 21, 2021
Last Updated
September 22, 2023
Sponsor
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04856085
Brief Title
Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection
Acronym
MARCH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
415 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Arm Title
Cohort 2a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total
Arm Title
Cohort 3a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Arm Title
Cohort 4a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks
Arm Title
Cohort 5a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Arm Title
Cohort 6a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks
Arm Title
Cohort 7a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks
Arm Title
Cohort 8a (VIR-2218 + VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks
Arm Title
Cohort 1b (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for 44 weeks
Arm Title
Cohort 2b (VIR-3434)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 for 20 weeks
Arm Title
Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks
Arm Title
Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks
Arm Title
Cohort 1d (VIR-2218 + PEG-IFNα)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-2218 + PEG-IFNα for 48 weeks
Arm Title
Cohort 2d (VIR-3434 + PEG-IFNα)
Arm Type
Experimental
Arm Description
Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
VIR-2218 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
VIR-3434
Intervention Description
VIR-3434 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
PEG-IFNα
Intervention Description
PEG-IFNα given by subcutaneous injection
Primary Outcome Measure Information:
Title
Proportion of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Up to 110 weeks
Title
Proportion of participants with serious adverse events (SAEs)
Time Frame
Up to 116 weeks
Title
Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment
Time Frame
Up to 48 weeks
Title
Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment
Time Frame
Up to 72 weeks
Secondary Outcome Measure Information:
Title
Absolute serum HBsAg and change from baseline across all timepoints in the study
Time Frame
Up to 110 weeks
Title
Nadir and maximum reduction of serum HBsAg from baseline
Time Frame
Up to 110 weeks
Title
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
Title
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
Title
For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Time Frame
Up to 110 weeks
Title
Cmax
Time Frame
Up to 110 weeks
Title
Clast
Time Frame
Up to 110 weeks
Title
Tmax
Time Frame
Up to 110 weeks
Title
Tlast
Time Frame
Up to 110 weeks
Title
AUCinf
Time Frame
Up to 110 weeks
Title
AUClast
Time Frame
Up to 110 weeks
Title
%AUCexp
Time Frame
Up to 110 weeks
Title
t1/2
Time Frame
Up to 110 weeks
Title
λz
Time Frame
Up to 110 weeks
Title
Vz/F
Time Frame
Up to 110 weeks
Title
CL/F
Time Frame
Up to 110 weeks
Title
Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434
Time Frame
Up to 110 weeks
Title
Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation
Time Frame
Up to 60 weeks
Title
Proportion of participants meeting criteria for NRTI retreatment
Time Frame
Up to 110 weeks
Title
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
Title
Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment
Time Frame
Up to 48 weeks
Title
Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment
Description
48 weeks treatment + 24 weeks post-end of treatment
Time Frame
Up to 72 weeks
Title
Proportion of participants with anti-HBs seroconversion
Time Frame
Up to 110 weeks
Title
Time to achieve nadir of serum HBsAg
Time Frame
Up to 110 weeks
Title
Time to achieve serum HBsAg loss
Time Frame
Up to 110 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Inquiry
Phone
415-654-5281
Email
clinicaltrials@vir.bio
Facility Information:
Facility Name
Investigative Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Toronto
ZIP/Postal Code
2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Toronto
ZIP/Postal Code
3M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Vancouver
ZIP/Postal Code
2C7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hong Kong
State/Province
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hong Kong
State/Province
Tai Po
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Busan
ZIP/Postal Code
49421
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Chisinau
ZIP/Postal Code
MD 2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Chiayi City
ZIP/Postal Code
60041
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Kaohsiung City
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
E11FR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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