VIR-2218 for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Inland Empire Clinical Trials, Rialto, CA
Hepatic Impairment+1 More
VIR-2218 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to evaluate single-dose PK of VIR-2218 following a SC injection of VIR-2218 administered at a dose up to 200 mg in participants with liver cirrhosis with various degrees of impaired hepatic function compared with healthy participants with normal hepatic function.

Eligible Conditions

  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatic Impairment

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 12 Weeks

12 Weeks
5 days
Primary Objective

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatic Impairment

Side Effects for

Part A SAD: VIR-2218 600 mg
17%Respiratory tract infection
17%Injection site bruising
17%Injection site pain
17%Sneezing
17%Nausea
17%Abdominal pain
0%Viral upper respiratory tract
0%Medial tibial stress syndrome
0%Myalgia
0%Dizziness
0%Lethargy
0%Urinary tract infection
0%Dry throat
0%Epistaxis
0%Dermatitis contact
0%Hypophosphataemia
0%Hypoaesthesia
0%Viral infection
0%Contusion
0%Neck pain
0%Muscle strain
0%Upper respiratory tract infection
0%Dehydration
0%Oropharyngeal pain
0%Cough
0%Influenza like illness
0%Injection site discomfort
0%Abdominal pain upper
0%Constipation
0%Pyrexia
0%Influenza
0%Eye contusion
0%Limb injury
0%Cardiac murmur
0%Urticaria
0%Headache
0%Abdominal discomfort
0%Palpitations
0%Vomiting
0%Gastroenteritis
0%Toothache
0%Paraesthesia oral
0%Night sweats
0%Fatigue
0%Catheter site pain
0%Rhinorrhoea
0%Rash
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT03672188) in the Part A SAD: VIR-2218 600 mg ARM group. Side effects include: Respiratory tract infection with 17%, Injection site bruising with 17%, Injection site pain with 17%, Sneezing with 17%, Nausea with 17%.

Trial Design

3 Treatment Groups

Cohort 3: CPT-A (mild HI) participants and matched healthy participants
1 of 3
Cohort 2: CPT-C (severe HI) participants and matched healthy participants
1 of 3
Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will...
1 of 3
Experimental Treatment

48 Total Participants · 3 Treatment Groups

Primary Treatment: VIR-2218 · No Placebo Group · Phase 1

Cohort 3: CPT-A (mild HI) participants and matched healthy participants
Drug
Experimental Group · 1 Intervention: VIR-2218 · Intervention Types: Drug
Cohort 2: CPT-C (severe HI) participants and matched healthy participants
Drug
Experimental Group · 1 Intervention: VIR-2218 · Intervention Types: Drug
Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first
Drug
Experimental Group · 1 Intervention: VIR-2218 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~110

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Closest Location: Inland Empire Clinical Trials · Rialto, CA
Photo of california 1Photo of california 2Photo of california 3
2020First Recorded Clinical Trial
2 TrialsResearching Hepatic Impairment
3 CompletedClinical Trials

Who is running the clinical trial?

Vir Biotechnology, Inc.Lead Sponsor
21 Previous Clinical Trials
9,437 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 70 years.
You have a calculated body mass index (BMI) of 18.5 to 40 kg/m2.
You are a healthy matched participant.
You have hepatic impairment.
You have a CPT score of 7-9 for moderate HI at screening and on Day 1 of study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.