Assessing the effects of liver impairment on new treatments for hepatitis
A Phase 1 Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Monotherapy and Combination Therapy in Adult Participants With Hepatic Impairment
This study is testing how well two new drugs for hepatitis work and how safe they are for people with liver problems, specifically those with cirrhosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Vir Biotechnology, Inc. Industry-sponsored |
| Locations | 5 sites (Rialto, California and 4 other locations) |
| Trial ID | NCT05484206 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics, safety, and tolerability of two investigational drugs, VIR-2218 and VIR-3434, in individuals with hepatic impairment, specifically those with cirrhosis. Participants will receive either a single dose of VIR-2218, VIR-3434, or a combination of both, with the aim of understanding how liver function affects drug exposure. The study will categorize participants based on the Child-Pugh-Turcotte scoring system to ensure appropriate grouping. Enrollment will occur in a non-randomized manner across multiple cohorts.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with varying degrees of hepatic impairment and stable health conditions.
Not a fit: Patients with chronic HBV and HDV infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with hepatic impairment and hepatitis.
How similar studies have performed: Previous studies have shown promise in similar approaches, but this specific combination and focus on hepatic impairment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rialto, California and 4 other locations
- Inland Empire Clinical Trials — Rialto, California, United States (Recruiting)
- Orange County Research Center — Tustin, California, United States (Recruiting)
- CenExel Research Centers of America — Hollywood, Florida, United States (Withdrawn)
- Floridian Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Texas Liver Institute — San Antonio, Texas, United States (Terminated)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.