Actively Recruiting
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
Led by Vir Biotechnology, Inc. · Updated on 2025-06-13
144
Participants Needed
5
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, 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 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.
CONDITIONS
Official 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
- Body mass index (BMI) between 18.5 and 40 kg/m2
- Estimated glomerular filtration rate (eGFR) of 60 mL/min or higher
- Healthy participants must be in good health based on medical history, vital signs, physical exam, and lab tests
- Participants with hepatic impairment must be stable and otherwise healthy except for liver insufficiency
- Chronic stable mild, moderate, or severe hepatic impairment with CPT scores 5-6 (mild), 7-9 (moderate), or 10-15 (severe)
- Hepatic impairment must be clinically stable 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, active hepatitis B or D, or hepatitis E viruses
- For healthy participants: blood pressure or heart rate outside specified ranges
- Use of medications other than vitamins or hormonal contraceptives within 30 days before study start
- For hepatic impaired participants: unstable medication doses or regimens
- Acute or worsening chronic hepatitis
- Need for frequent paracentesis (more than once a month)
- Refractory encephalopathy or major central nervous system issues
- History of serious gastrointestinal bleeding in past 6 months
- Presence of TIPS (shunt) placement
- Hepatopulmonary or hepatorenal syndrome
- Primarily cholestatic liver diseases
- History of or currently listed for liver transplantation
AI-Screening
AI-Powered Screening
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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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