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Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Sponsor
Vir Biotechnology, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04412863
Collaborator
Alnylam Pharmaceuticals (Industry)
84
Enrollment
22
Locations
9
Arms
44.9
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a
Actual Study Start Date :
Jul 3, 2020
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1d

VIR-2218 given by subcutaneous injection

Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Cohort 2d

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Drug: VIR-2218
VIR-2218 given by subcutaneous injection

Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 3d

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 1e

    VIR-2218 given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection
    Experimental: Cohort 2e

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 3e

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 1f

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 2f

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•
    Experimental: Cohort 3f

    VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

    Drug: VIR-2218
    VIR-2218 given by subcutaneous injection

    Drug: pegylated interferon-alfa 2a
    pegylated interferon-alfa 2a given by subcutaneous injection
    Other Names:
  • pegylated interferon alpha-2a
  • PEG-IFNα

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with Adverse Events as assessed by CTCAE v5.0 [Up to 148 Weeks]

    2. Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings [Up to 148 Weeks]

    Secondary Outcome Measures

    1. Mean maximum reduction of serum HBsAg at any timepoint [Up to 144 Weeks]

    2. Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint [Up to 144 Weeks]

    3. Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months [Up to 144 Weeks]

    4. Number of subjects with anti-HBs seroconversion at any timepoint [Up to 144 Weeks]

    5. For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint [Up to 96 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female of ages 18 - 65

    • Chronic HBV infection for >/= 6 months

    Exclusion Criteria:

    • Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation

    • Significant fibrosis or cirrhosis

    • History or evidence of drug or alcohol abuse

    • History of intolerance to SC injection

    • History of chronic liver disease from any cause other than chronic HBV infection

    • History of hepatic decompensation

    • Any prior receipt of an interferon product

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigative Site Birtinya Queensland Australia 4575
    2 Investigative Site Fitzroy Victoria Australia 3168
    3 Investigative site Hong Kong Hong Kong
    4 Investigative Site Busan Korea, Republic of 49241
    5 Investigative Site Chuncheon Korea, Republic of 24253
    6 Investigative Site Daegu Korea, Republic of 41944
    7 Investigative Site Seoul Korea, Republic of 03080
    8 Investigative Site Seoul Korea, Republic of 05505
    9 Investigative Site Yangsan Korea, Republic of 50612
    10 Investigative Site Batu Caves Malaysia 68100
    11 Investigative Site Kajang Malaysia 43000
    12 Investigative Site Kuala Lumpur Malaysia 59100
    13 Investigative Site Kuantan Malaysia 25100
    14 Investigative Site Auckland New Zealand 1010
    15 Investigative Site Auckland New Zealand 2025
    16 Investigative Site Bangkok Thailand 10330
    17 Investigative Site Bangkok Thailand 10400
    18 Investigative Site Bangkok Thailand 10700
    19 Investigative Site Chiang Mai Thailand 50200
    20 Investigative Site Hat Yai Thailand 90110
    21 Investigative Site Khlong Luang Thailand 12120
    22 Investigative Site Khon Kaen Thailand 40002

    Sponsors and Collaborators

    • Vir Biotechnology, Inc.
    • Alnylam Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vir Biotechnology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04412863
    Other Study ID Numbers:
    • VIR-2218-1001-PEG-IFNα
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic
    Interferons
    Interferon-alpha
    Interferon alpha-2
    Peginterferon alfa-2a

    Study Results

    No Results Posted as of Jan 11, 2022