144 Participants Needed

VIR-2218 + VIR-3434 for Liver Cirrhosis

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Vir Biotechnology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

If you are a healthy participant, you must stop taking any prescription or over-the-counter medications (except vitamins and hormonal contraceptives) 30 days before the study. If you have liver impairment, you need to be on a stable dose and regimen of your current medications.

What is the purpose of this trial?

This trial is testing new drugs VIR-2218 and VIR-3434, either alone or together, in people with liver damage. The goal is to see how these drugs move through the body and if they are safe for patients with liver problems.

Eligibility Criteria

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.

Inclusion Criteria

Healthy matched participants must, in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
My liver is not working well, but I am healthy enough for the study according to my doctor.
CPT score of 5 to 6 for mild HI at screening
See 5 more

Exclusion Criteria

I am currently listed for or have had a liver transplant.
Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)
I have HIV, hepatitis A, B, C, D, or E but my viral load is undetectable if positive for HCV or HDV.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic exposure after treatment

4 weeks

Treatment Details

Interventions

  • VIR-2218
  • VIR-3434
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials
30
Recruited
13,300+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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