Hepatic ImpairmentPhase 1NCT05484206
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
A Phase 1 study testing VIR-2218 and VIR-3434 in people with Hepatic Impairment and Cirrhosis, run by Vir Biotechnology, Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Cirrhosis
- What is being tested?
- VIR-2218 and VIR-3434
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Sep 2022to 9 Dec 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
- 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
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- 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
Who cannot join
- 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
- 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
- Not on stable dose and regimen of any medication
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Floridian Clinical Research
Miami Lakes, Florida, 33016
Inland Empire Clinical Trials
Rialto, California, 92377
Texas Liver Institute
San Antonio, Texas, 78215
Orange County Research Center
Tustin, California, 92790
About this study
Official title: 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
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.
Read the detailed description
Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.
- Conditions
- Hepatic Impairment, Cirrhosis
- Being tested
- VIR-2218, VIR-3434
- Keywords
- siRNA, Monoclonal antibody, HDV, Compensated Cirrhosis, Decompensated Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-2218Drug
VIR-2218 given by subcutaneous injection.
VIR-3434Drug
VIR-3434 given by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first | Experimental | All participants in Cohort 1 will be receiving VIR-2218 monotherapy. Receives: Drug: VIR-2218 |
| Cohort 2: CPT-C (severe HI) participants and matched healthy participants | Experimental | This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy. Receives: Drug: VIR-2218 |
| Cohort 3: CPT-A (mild HI) participants and matched healthy participants | Experimental | This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy. Receives: Drug: VIR-2218 |
| Cohort 4: CPT-A (mild HI) participants and matched healthy participants | Experimental | All participants in Cohort 4 will be receiving VIR-3434 monotherapy. Receives: Drug: VIR-3434 |
| Cohort 5: CPT-B (moderate HI) participants and matched healthy participants | Experimental | All participants in Cohort 5 will be receiving VIR-3434 monotherapy. Receives: Drug: VIR-3434 |
| Cohort 6: CPT-C (severe HI) participants and matched healthy participants | Experimental | This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy. Receives: Drug: VIR-3434 |
| Cohort 7: CPT-A (mild HI) and matched healthy participants | Experimental | All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy. Receives: Drug: VIR-2218; Drug: VIR-3434 |
| Cohort 8: CPT-B (moderate HI) and matched healthy participants | Experimental | All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy. Receives: Drug: VIR-2218; Drug: VIR-3434 |
| Cohort 9: CPT-C (severe HI) and matched healthy participants | Experimental | This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy. Receives: Drug: VIR-2218; Drug: VIR-3434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Measured: 5 days
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Measured: 5 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218
Measured: 5 days
Maximum observed Plasma concentration (Cmax) of VIR-3434
Measured: 18 weeks
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-3434
Measured: 18 weeks
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-3434
Measured: 18 weeks
Secondary outcomes (2)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Up to 18 Weeks
Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start21 Sep 2022
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484206
- Sponsor's protocol ID
- VIR-2218-V107
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No