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Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

NCT ID: NCT03672188

Last Updated: 2021-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2020-09-03

Brief Summary

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This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B \& Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.

Detailed Description

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Conditions

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Chronic Hepatitis B

Keywords

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Hepatitis B Virus Chronic Hepatitis B HBV Hepatitis

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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Part A: SAD VIR-2218 50 mg

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD VIR-2218 100 mg

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD VIR-2218 200 mg

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD VIR-2218 400 mg

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD VIR-2218 600 mg

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD VIR-2218 900 mg

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part A: SAD Placebo

Healthy subjects received a single dose of placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Part B: MAD VIR-2218 20 mg

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part B: MAD VIR-2218 50 mg

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part B: MAD VIR-2218 100 mg

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part B: MAD VIR-2218 200 mg

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part C: MAD VIR-2218 50 mg

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part C: MAD VIR-2218 200 mg

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

Group Type EXPERIMENTAL

VIR-2218

Intervention Type DRUG

VIR-2218 given by subcutaneous injection

Part B: MAD Placebo

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Part C: MAD Placebo

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Interventions

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VIR-2218

VIR-2218 given by subcutaneous injection

Intervention Type DRUG

Placebo

Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female age 18 - 55
* BMI 18 - 32 kg/m\^2


* Male or female age 18 - 65
* BMI 18 - 32 kg/m\^2
* 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 intolerance to SC injection

Parts B/C MAD:


* 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

Yes

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

Birtinya, Queensland, Australia

Site Status

Investigative Site

Clayton, Victoria, Australia

Site Status

Investigative Site

Fitzroy, Victoria, Australia

Site Status

Investigative Site

Hong Kong, , Hong Kong

Site Status

Investigative Site

Auckland, , New Zealand

Site Status

Investigative Site

Auckland, , New Zealand

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

Bangkok, , Thailand

Site Status

Investigative Site

Bangkok, , Thailand

Site Status

Investigative Site

Bangkok, , Thailand

Site Status

Investigative Site

Hat Yai, , Thailand

Site Status

Investigative Site

Khon Kaen, , Thailand

Site Status

Countries

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Australia Hong Kong New Zealand South Korea Thailand

References

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Yuen MF, Lim YS, Yoon KT, Lim TH, Heo J, Tangkijvanich P, Tak WY, Thanawala V, Cloutier D, Mao S, Arizpe A, Cathcart AL, Gupta SV, Hwang C, Gane E. VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study. Lancet Gastroenterol Hepatol. 2024 Dec;9(12):1121-1132. doi: 10.1016/S2468-1253(24)00237-1. Epub 2024 Oct 8.

Reference Type DERIVED
PMID: 39389081 (View on PubMed)

Gane E, Lim YS, Kim JB, Jadhav V, Shen L, Bakardjiev AI, Huang SA, Cathcart AL, Lempp FA, Janas MM, Cloutier DJ, Kaittanis C, Sepp-Lorenzino L, Hinkle G, Taubel J, Haslett P, Milstein S, Anglero-Rodriguez YI, Hebner CM, Pang PS, Yuen MF. Evaluation of RNAi therapeutics VIR-2218 and ALN-HBV for chronic hepatitis B: Results from randomized clinical trials. J Hepatol. 2023 Oct;79(4):924-932. doi: 10.1016/j.jhep.2023.05.023. Epub 2023 Jun 7.

Reference Type DERIVED
PMID: 37290591 (View on PubMed)

Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.

Reference Type DERIVED
PMID: 34741731 (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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VIR-2218-1001

Identifier Type: -

Identifier Source: org_study_id