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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856085
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Brief Summary:
This is a phase 2 study in which subjects 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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: VIR-2218 Drug: VIR-3434 Drug: PEG-IFNα Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2021
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027


Arm Intervention/treatment
Experimental: Cohort 1a (VIR-2218 + VIR-3434)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects 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)
Subjects will receive multiple doses of VIR-3434 for 44 weeks
Drug: VIR-3434
VIR-3434 given by subcutaneous injection

Experimental: Cohort 2b (VIR-3434)
Subjects 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)
Subjects 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)
Subjects 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




Primary Outcome Measures :
  1. Proportion of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 110 weeks ]
  2. Proportion of subjects with serious adverse events (SAEs) [ Time Frame: Up to 116 weeks ]
  3. Proportion of subjects with HBsAg loss at end of treatment [ Time Frame: Up to 48 weeks ]
  4. Proportion of subjects with HBsAg loss at 24 weeks post-end of treatment [ Time Frame: Up to 72 weeks ]

Secondary Outcome Measures :
  1. Absolute serum HBsAg and change from baseline across all timepoints in the study [ Time Frame: Up to 110 weeks ]
  2. Time to achieve the nadir and maximum reduction of serum HBsAg from baseline [ Time Frame: Up to 110 weeks ]
  3. Proportion of subjects with serum HBsAg loss (defined as undetectable HBsAg) [ Time Frame: Up to 110 weeks ]
  4. For hepatitis B e-antigen (HBeAg)-positive subjects: Proportion of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint [ Time Frame: Up to 110 weeks ]
  5. For HBeAg-positive subjects: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion [ Time Frame: Up to 110 weeks ]
  6. Cmax [ Time Frame: Up to 64 weeks ]
  7. Clast [ Time Frame: Up to 64 weeks ]
  8. Tmax [ Time Frame: Up to 64 weeks ]
  9. Tlast [ Time Frame: Up to 64 weeks ]
  10. AUCinf [ Time Frame: Up to 64 weeks ]
  11. AUClast [ Time Frame: Up to 64 weeks ]
  12. %AUCexp [ Time Frame: Up to 64 weeks ]
  13. t1/2 [ Time Frame: Up to 64 weeks ]
  14. λz [ Time Frame: Up to 64 weeks ]
  15. Vz/F [ Time Frame: Up to 64 weeks ]
  16. CL/F [ Time Frame: Up to 64 weeks ]
  17. Number of subjects with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434 [ Time Frame: Up to 110 weeks ]
  18. Proportion of subjects meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation [ Time Frame: Up to 60 weeks ]
  19. Proportion of subjects meeting criteria for NRTI retreatment [ Time Frame: Up to 110 weeks ]
  20. Proportion of subjects achieving undetectable hepatitis B surface antigen (HBsAg) and sustained suppression of HBV DNA [target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs [ Time Frame: Up to 110 weeks ]
  21. Proportion of subjects with serum HBsAg < 10 IU/mL at end of treatment [ Time Frame: Up to 48 weeks ]
  22. Proportion of subjects with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment [ Time Frame: Up to 72 weeks ]
    48 weeks and 24 weeks post-end of treatment

  23. Proportion of subjects with anti-HBs seroconversion [ Time Frame: Up to 110 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856085


Contacts
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Contact: Study Inquiry 415-654-5281 clinicaltrials@vir.bio

Locations
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United States, California
Investigative Site Not yet recruiting
San Francisco, California, United States, 94143
United States, Florida
Investigative Site Not yet recruiting
Miami, Florida, United States, 33146
Investigative Site Not yet recruiting
Orlando, Florida, United States, 32803
United States, Maryland
Investigative Site Not yet recruiting
Baltimore, Maryland, United States, 21218
United States, New Jersey
Investigative Site Not yet recruiting
Hillsborough, New Jersey, United States, 08844
Canada
Investigative Site Not yet recruiting
Toronto, Canada, 2C4
Investigative Site Not yet recruiting
Toronto, Canada, 3M1
Investigative Site Not yet recruiting
Vancouver, Canada, 2C7
Germany
Investigative Site Not yet recruiting
Frankfurt, Germany, 60590
Investigative Site Not yet recruiting
Hannover, Germany, 30625
Investigative Site Not yet recruiting
Mannheim, Germany, 68167
Investigative Site Not yet recruiting
Ulm, Germany, 89081
Hong Kong
Investigative Site Recruiting
Hong Kong, Shatin, Hong Kong
Investigative Site Recruiting
Hong Kong, Tai Po, Hong Kong
Investigative Site Recruiting
Hong Kong, Hong Kong
Korea, Republic of
Investigative Site Recruiting
Busan, Korea, Republic of, 49421
Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Investigative Site Recruiting
Yangsan, Korea, Republic of, 50612
Malaysia
Investigative Site Recruiting
Batu Caves, Malaysia, 68100
Investigative Site Recruiting
Kajang, Malaysia, 43000
Investigative Site Recruiting
Kuala Lumpur, Malaysia, 59100
Moldova, Republic of
Investigative Site Recruiting
Chisinau, Moldova, Republic of
New Zealand
Investigative Site Recruiting
Auckland, New Zealand, 1010
Investigative Site Recruiting
Auckland, New Zealand, 2025
Investigative Site Recruiting
Hamilton, New Zealand, 3204
Investigative Site Recruiting
Tauranga, New Zealand, 3110
Investigative Site Recruiting
Wellington, New Zealand, 6021
Romania
Investigative Site Recruiting
Bucharest, Romania
Taiwan
Investigative Site Recruiting
Chiayi City, Taiwan, 60041
Investigative Site Recruiting
Kaohsiung City, Taiwan, 80756
Investigative Site Not yet recruiting
Kaohsiung City, Taiwan, 83301
Investigative Site Recruiting
Taichung City, Taiwan, 40705
Investigative Site Recruiting
Taipei City, Taiwan, 100
Investigative Site Recruiting
Taoyuan City, Taiwan, 33305
Ukraine
Investigative Site Recruiting
Kyiv, Ukraine, 08132
United Kingdom
Investigative Site Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Investigative Site Not yet recruiting
London, United Kingdom, E1 4NS
Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Investigative Site Recruiting
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Vir Biotechnology, Inc.
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04856085    
Other Study ID Numbers: VIR-2218-1006
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vir Biotechnology, Inc.:
Hepatitis B Virus
Chronic Hepatitis B
HBV
Hepatitis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Virus Diseases
Herpesviridae Infections
Hepatitis
Hepatitis, Chronic
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections