VIR-2218 for Hepatic Impairment
Phase-Based Progress Estimates
Effectiveness
Safety
Inland Empire Clinical Trials, Rialto, CA
Hepatic Impairment+1 More
VIR-2218 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 12 Weeks
12 Weeks
5 days
Primary Objective
Trial Safety
Safety Progress
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
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: DrugCohort 2: CPT-C (severe HI) participants and matched healthy participants
Drug
Experimental Group · 1 Intervention: VIR-2218 · Intervention Types: DrugCohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first
Drug
Experimental Group · 1 Intervention: VIR-2218 · Intervention Types: DrugTreatment
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
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 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.
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Conditions
Cancer Related
Treatments