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Antisense Oligonucleotide

VIR-2218 + VIR-3434 for Liver Cirrhosis

Phase 1
Recruiting
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be ≥18 to ≤70 years of age at screening
All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights

Study Summary

This trial is testing a new drug for people with liver cirrhosis to see how it is metabolized in different degrees of impaired hepatic function compared to people with normal hepatic function.

Who is the study for?
This trial is for adults aged 18-70 with liver cirrhosis or impairment, stable health, and a BMI of 18.5-40 kg/m2. They must have a CPT score indicating mild to severe hepatic impairment but can't be on certain medications, have unstable heart conditions, active infections like HIV/HBV/HCV/HDV/HEV (with some exceptions), recent variceal bleeding, or be listed for liver transplantation.Check my eligibility
What is being tested?
The study tests the effects of single doses of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC alone or in combination on people with different levels of liver function as classified by the Child-Pugh-Turcotte score. It aims to understand how these drugs are processed by the body and their safety profile in those with hepatic issues.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones related to similar treatments may include injection site reactions, fatigue, nausea, potential allergic responses and possibly changes in liver enzymes which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My kidney function, measured by eGFR, is 60 mL/min or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-3434
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218
+3 more
Secondary outcome measures
Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Side effects data

From 2020 Phase 1 & 2 trial • 82 Patients • NCT03672188
50%
Headache
17%
Abdominal discomfort
17%
Dry throat
17%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A SAD: VIR-2218 100 mg
Part B MAD: VIR-2218 20 mg
Part A SAD: VIR-2218 50 mg
Part A SAD: VIR-2218 200 mg
Part A SAD: VIR-2218 400 mg
Part A SAD: VIR-2218 600 mg
Part A SAD: VIR-2218 900 mg
Part A SAD: Placebo
Part B MAD: VIR-2218 50 mg
Part B MAD: VIR-2218 100 mg
Part B MAD: VIR-2218 200 mg
Part C MAD: VIR-2218 50 mg
Part C MAD: VIR-2218 200 mg
Part B MAD: Placebo
Part C MAD: Placebo

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 9: CPT-C (severe HI) and matched healthy participantsExperimental Treatment2 Interventions
This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy.
Group II: Cohort 8: CPT-B (moderate HI) and matched healthy participantsExperimental Treatment2 Interventions
All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy.
Group III: Cohort 7: CPT-A (mild HI) and matched healthy participantsExperimental Treatment2 Interventions
All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy.
Group IV: Cohort 6: CPT-C (severe HI) participants and matched healthy participantsExperimental Treatment1 Intervention
This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy.
Group V: Cohort 5: CPT-B (moderate HI) participants and matched healthy participantsExperimental Treatment1 Intervention
All participants in Cohort 5 will be receiving VIR-3434 monotherapy.
Group VI: Cohort 4: CPT-A (mild HI) participants and matched healthy participantsExperimental Treatment1 Intervention
All participants in Cohort 4 will be receiving VIR-3434 monotherapy.
Group VII: Cohort 3: CPT-A (mild HI) participants and matched healthy participantsExperimental Treatment1 Intervention
This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy.
Group VIII: Cohort 2: CPT-C (severe HI) participants and matched healthy participantsExperimental Treatment1 Intervention
This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy.
Group IX: Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated firstExperimental Treatment1 Intervention
All participants in Cohort 1 will be receiving VIR-2218 monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~110
VIR-3434
2020
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
13,114 Total Patients Enrolled

Media Library

VIR-2218 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05484206 — Phase 1
Liver Disease Research Study Groups: Cohort 4: CPT-A (mild HI) participants and matched healthy participants, Cohort 5: CPT-B (moderate HI) participants and matched healthy participants, Cohort 6: CPT-C (severe HI) participants and matched healthy participants, Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first, Cohort 3: CPT-A (mild HI) participants and matched healthy participants, Cohort 7: CPT-A (mild HI) and matched healthy participants, Cohort 2: CPT-C (severe HI) participants and matched healthy participants, Cohort 8: CPT-B (moderate HI) and matched healthy participants, Cohort 9: CPT-C (severe HI) and matched healthy participants
Liver Disease Clinical Trial 2023: VIR-2218 Highlights & Side Effects. Trial Name: NCT05484206 — Phase 1
VIR-2218 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05484206 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for participant enrollment in this research trial?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which went up on September 21st 2022, is currently seeking participants. The study aims to enroll 144 patients from 5 different sites."

Answered by AI

What potential side effects should people be aware of with VIR-2218?

"Due to the limited clinical data surrounding VIR-2218, our team at Power has assigned it a score of 1 on its safety scale. This is reflective of this experimental drug being in Phase 1 trials with very little supporting evidence for efficacy or safety."

Answered by AI

Are there any vacancies for prospective participants in this investigation?

"Affirmative. Clinicaltrials.gov records that this research is presently recruiting patients, which commenced on September 21st 2022 and was most recently updated November 28th 2022. 144 participants are needed to be enrolled between 5 different locations."

Answered by AI

How many healthcare facilities have adopted this clinical trial?

"Five clinical trial sites are currently running this investigation: Rialto, Miami Lakes, and Miami along with 5 other locations. To minimize travel needs, applicants should prioritize selecting the nearest centre to them."

Answered by AI

Is this experimental research recruiting seniors as participants?

"Individuals between 18 and 70 are eligible to apply for this medical trial. Additionally, there are 101 studies available for minors younger than 18 and 616 trials open to those over 65 years old."

Answered by AI

Am I eligible to participate in this clinical investigation?

"This medical trial is in search of 144 patients with hepatic insufficiency between the ages 18 and 70. The enrolment criteria are as follows: A BMI range from 18.5 to 40 kg/m2, an eGFR ≥ 60mL/min as calculated by MDRD equation, good overall health based on medical history, physical examination, vital signs and laboratory tests for healthy participants; chronic stable mild-to-severe HI (excluding HBV or HDV) that has been clinically steady per Investigator assessment for a minimum of one month before screening; CPT scores 5–6 for mild HI at screening or 7–"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
2022. "Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05484206.
~56 spots leftby Apr 2025
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