Actively Recruiting
Pharmacokinetics and Safety Study of VIR-2218 and VIR-3434 in Adults With Hepatic Impairment Using Single-Dose Monotherapy or Combination Therapy
Led by Vir Biotechnology, Inc. · Updated on 2025-06-13
144
Participants Needed
5
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how liver problems affect the behavior and safety of two study drugs, VIR-2218 and VIR-3434, given alone or together. This study involves adults with different levels of liver impairment, classified by the Child-Pugh-Turcotte system, including those with cirrhosis. The goal is to understand how these drugs act in the body and how safe they are in people with liver issues. The study includes up to nine groups, each receiving either VIR-2218 alone, VIR-3434 alone, or both drugs combined. Participants receive a single dose by subcutaneous injection. Some groups focus on mild, moderate, or severe liver impairment, while others include healthy matched participants for comparison. The study is not randomized and allows optional cohorts based on previous group participation. Participants will undergo tests to measure drug levels in their blood over days to weeks, with primary outcomes focused on maximum drug concentration and overall exposure. Safety is monitored by recording side effects and immune reactions for up to 18 weeks. The total study duration varies by group, with detailed assessments of physical health, laboratory tests, and pharmacokinetics to evaluate drug behavior and safety.
CONDITIONS
Brief Title
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 to 70 years of age at screening
- Must have a body mass index between 18.5 and 40 kg/m2
- Must have kidney function with eGFR of 60 mL/min or higher
- Healthy matched participants must be in good health based on medical history, vital signs, physical exam, and labs
- Participants with hepatic impairment must be clinically stable and healthy aside from liver issues
- Participants must have chronic, stable mild, moderate, or severe hepatic impairment as defined by Child-Pugh-Turcotte scores (5-6 mild, 7-9 moderate, 10-15 severe) for at least 1 month before screening
You will not qualify if you...
- Unstable heart function or recent heart attack within 12 months
- Significant active cardiovascular disease or abnormal heart rhythms
- Infection with HIV, hepatitis A, chronic hepatitis B or D, or hepatitis E
- Healthy participants with abnormal blood pressure or heart rate outside specified ranges
- Use of prescription or over-the-counter medications (except vitamins or hormonal contraceptives) within 30 days before study start
- Participants with hepatic impairment not on stable medication doses
- Acute or worsening hepatitis
- Frequent need for paracentesis more than once a month
- Severe brain-related complications or encephalopathy
- Recent history of stomach or esophageal variceal bleeding within 6 months
- Having a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Presence of hepatopulmonary or hepatorenal syndrome
- Mainly cholestatic liver diseases
- History of or currently listed for liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks
Participants receive a single dose of VIR-2218, VIR-3434, or a combination of both by subcutaneous injection depending on their cohort assignment.
Multiple visits for pharmacokinetic sampling and safety assessments over 18 weeks
Duration - Up to 18 weeks
Participants are monitored for safety, adverse events, and antibody development after treatment.
Visits for safety monitoring and antibody assessments during the 18-week study period
Trial Site Locations
Total: 5 locations
1
Inland Empire Clinical Trials
Rialto, California, United States, 92377
Actively Recruiting
2
Orange County Research Center
Tustin, California, United States, 92790
Actively Recruiting
3
CenExel Research Centers of America
Hollywood, Florida, United States, 33024
Withdrawn
4
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
5
Texas Liver Institute
San Antonio, Texas, United States, 78215
Terminated
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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