Can two experimental drugs be used safely in people with cirrhosis?
NCT ID NCT05484206
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are studying how the body handles two experimental drugs, VIR-2218 and VIR-3434, in adults with cirrhosis and liver impairment. Participants receive a single injection of one drug or both together. The trial measures drug levels in the blood and checks for side effects, comparing results with healthy volunteers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VIR-2218 and VIR-3434, experimental injectable drugs given alone or together
- What this could lead to
- If the drugs behave safely in people with liver impairment, this could support testing them in this population for hepatitis B or D.
- What could go wrong
- This is a small phase 1 study with a single dose. It may not show how repeated doses behave, and liver impairment could change drug levels in unexpected ways.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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88 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Must be ≥18 to ≤70 years of age at screening * Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2 * All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation 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 Inclusion criteria: Hepatic impaired participants * Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations * Participant is considered to have chronic, stable moderate, severe, mild HI (of any etiology excluding chronic HBV and HDV) and has been clinically stable per Investigator assessment for at least 1 month prior to screening * CPT score of 5 to 6 for mild HI at screening * CPT score 7-9 for moderate HI at screening * CPT score 10-15 severe HI at screening Exclusion Criteria: * Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the Investigator, could interfere with the safety of the participant * Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment) * Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative hepatitis B surface antibody), hepatitis C virus (HCV), HDV or hepatitis E virus (HEV). HCV antibody positive participants with a negative HCV RNA are eligible. HDV antibody positive participants with a negative HDV RNA are eligible Exclusion criteria: Healthy matched participants * Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female participants or 45-100 bpm for male participants at screening * Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medication) within 30 days prior to D1 of study participation Exclusion criteria: Participants with Hepatic impairment * Not on stable dose and regimen of any medication * Acute or worsening chronic hepatitis * Participants requiring paracentesis more than once a month * Participants with refractory encephalopathy or significant Central Nervous System * History of gastric or esophageal variceal bleeding within the past 6 months * Participants with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement * Presence of hepatopulmonary or hepatorenal syndrome * Presence of primarily cholestatic liver diseases * History of or currently listed for liver transplantation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Floridian Clinical Research
Miami Lakes, Florida, 33016, United States
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Inland Empire Clinical Trials
Rialto, California, 92377, United States
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Orange County Research Center
Tustin, California, 92790, United States
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Texas Liver Institute
San Antonio, Texas, 78215, United States
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Other studies related to the condition(s) this trial covers.
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