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

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: NCT04412863
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
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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
Chronic Hepatitis B Drug: VIR-2218 Drug: pegylated interferon-alfa 2a Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 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 : July 3, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with Adverse Events as assessed by CTCAE v5.0 [ Time Frame: Up to 124 Weeks ]
  2. Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings [ Time Frame: Up to 124 Weeks ]

Secondary Outcome Measures :
  1. Mean maximum reduction of serum HBsAg at any timepoint [ Time Frame: Up to 120 Weeks ]
  2. Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint [ Time Frame: Up to 120 Weeks ]
  3. Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months [ Time Frame: Up to 120 Weeks ]
  4. Number of subjects with anti-HBs seroconversion at any timepoint [ Time Frame: Up to 120 Weeks ]
  5. For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint [ Time Frame: Up to 72 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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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 of non-childbearing potential age 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
Contacts and Locations
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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): NCT04412863


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

Locations
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Australia, Queensland
Investigative Site Not yet recruiting
Birtinya, Queensland, Australia, 4575
Australia, Victoria
Investigative Site Not yet recruiting
Fitzroy, Victoria, Australia, 3168
Hong Kong
Investigative site Not yet recruiting
Hong Kong, Hong Kong
Korea, Republic of
Investigative Site Not yet recruiting
Busan, Korea, Republic of, 49241
Investigative Site Not yet recruiting
Chuncheon, Korea, Republic of, 24253
Investigative Site Not yet recruiting
Daegu, Korea, Republic of, 41944
Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Investigative Site Not yet recruiting
Yangsan, Korea, Republic of, 50612
Malaysia
Investigative Site Not yet recruiting
Batu Caves, Malaysia, 68100
Investigative Site Not yet recruiting
Kajang, Malaysia, 43000
Investigative Site Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Investigative Site Not yet recruiting
Kuantan, Malaysia, 25100
New Zealand
Investigative Site Recruiting
Auckland, New Zealand, 1010
Investigative Site Recruiting
Auckland, New Zealand, 2025
Thailand
Investigative Site Not yet recruiting
Bangkok, Thailand, 10330
Investigative Site Not yet recruiting
Bangkok, Thailand, 10400
Investigative Site Not yet recruiting
Bangkok, Thailand, 10700
Investigative Site Not yet recruiting
Chiang Mai, Thailand, 50200
Investigative Site Not yet recruiting
Hat Yai, Thailand, 90110
Investigative Site Not yet recruiting
Khlong Luang, Thailand, 12120
Investigative Site Not yet recruiting
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals
More Information
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04412863    
Other Study ID Numbers: VIR-2218-1001-PEG-IFNα
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
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
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs