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Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

NCT ID: NCT04423393

Last Updated: 2024-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2022-11-25

Brief Summary

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This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection).

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Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VIR-3434

Group Type EXPERIMENTAL

VIR-3434

Intervention Type BIOLOGICAL

VIR-3434 given by subcutaneous injection or intravenous infusion.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Interventions

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VIR-3434

VIR-3434 given by subcutaneous injection or intravenous infusion.

Intervention Type BIOLOGICAL

Placebo

Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female age 18 - 55
* Weight 40-125 kg


* Male or female age 18 - 65
* Weight 40-125 kg
* Chronic HBV infection for \>/= 6 months

Exclusion Criteria

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* History or evidence of drug or alcohol abuse
* History of allergic reactions to monoclonal antibodies or antibody fragments
* History of anaphylaxis

CHB Patients:


* 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 to monoclonal antibodies or antibody fragments
* History of immune complex disease
* Active infection with HIV, HCV or hepatitis Delta virus
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

Essen, , Germany

Site Status

Investigative Site

Frankfurt, , Germany

Site Status

Investigative Site

Hanover, , Germany

Site Status

Investigative Site

Leipzig, , Germany

Site Status

Investigative Site

Mainz, , Germany

Site Status

Investigative Site

Mannheim, , Germany

Site Status

Investigative Site

Ulm, , Germany

Site Status

Investigative Site

Hong Kong, , Hong Kong

Site Status

Investigative Site

Auckland, , New Zealand

Site Status

Investigative Site

Havelock North, , New Zealand

Site Status

Investigative Site

Newtown, , New Zealand

Site Status

Investigative Site

Tauranga, , New Zealand

Site Status

Investigative Site

Bucharest, , Romania

Site Status

Investigative Site

Singapore, , Singapore

Site Status

Investigative Site

Singapore, , Singapore

Site Status

Investigative Site

Busan, , South Korea

Site Status

Investigative Site

Busan, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Seoul, , South Korea

Site Status

Investigative Site

Birmingham, , United Kingdom

Site Status

Investigative Site

London, , United Kingdom

Site Status

Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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Germany Hong Kong New Zealand Romania Singapore South Korea United Kingdom

References

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Vincenzetti L, Wong R, Marzi R, Guarino B, Stefanutti E, Gupta SV, Rosen LE, Belnap DM, Wang L, Chen YP, di Iulio J, Momin A, Tracy KE, Deshpande S, Errico JM, Giovannoni F, Sprugasci N, Peter A, Seu L, Cloutier D, Tay CH, Snell G, Czudnochowski N, Lempp FA, Havenar-Daughton C, Benigni F, Lanzavecchia A, Agarwal K, Yuen MF, Wedemeyer H, Gane E, Arvin A, Corti D, Schmid MA. Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells. J Hepatol. 2025 Aug 27:S0168-8278(25)02452-3. doi: 10.1016/j.jhep.2025.08.016. Online ahead of print.

Reference Type DERIVED
PMID: 40882923 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-003837-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIR-3434-1002

Identifier Type: -

Identifier Source: org_study_id

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