Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

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

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-18

Study Completion Date

2021-09-30

Brief Summary

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This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.

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Detailed Description

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Conditions

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Hepatitis B, Chronic

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-2218

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

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Placebo

Drug: Placebo Saline given by subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline given by subcutaneous injection

Interventions

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VIR-2218

VIR-2218 given by subcutaneous injection

Intervention Type DRUG

Placebo

Saline given by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female age 18 - 65;
* Weight ≥ 40 kg to ≤ 125 kg;
* Chronic HBV infection as defined by a positive serum HBsAg 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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No