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NCT05484206 · ClinicalTrials.gov registry record · Phase 1
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
A Phase 1 study of Cirrhosis and Hepatic Impairment, sponsored by Vir Biotechnology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
- 5
- Study locations
NCT05484206: Recruiting Phase 1 study of Cirrhosis and Hepatic Impairment, sponsored by Vir Biotechnology.
NCT05484206 is a Phase 1 study of Cirrhosis and Hepatic Impairment that is actively recruiting participants, run by Vir Biotechnology. The registered enrollment target is 144 participants, below the 90,406-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05484206, a Phase 1 study of Cirrhosis and Hepatic Impairment, is actively recruiting participants, sponsored by Vir Biotechnology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
- 5
- Study locations
Study 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 using the Child-Pugh-Turcotte (CPT) categorization.
Conditions Studied
Interventions
- DRUG VIR-2218
- DRUG VIR-3434
Study Locations (5)
California
- Inland Empire Clinical Trials - Rialto
- Orange County Research Center - Tustin
Florida
- CenExel Research Centers of America - Hollywood
- Floridian Clinical Research - Miami Lakes
Texas
- Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT05484206 shows while recruiting
NCT05484206 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 90,406-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which VIR-2218 is the first listed.
NCT05484206 lists 5 locations in 3 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT05484206 about?
NCT05484206 is a clinical study titled "Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434". 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 Impai...
What is the current status of trial NCT05484206?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2022-09-21. Estimated completion is 2027-04-30.
What conditions does trial NCT05484206 study?
This clinical trial studies the following conditions: Cirrhosis, Hepatic Impairment.
What interventions are being tested in trial NCT05484206?
The interventions under investigation include: VIR-2218 (DRUG), VIR-3434 (DRUG).
Who is sponsoring clinical trial NCT05484206?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05484206 being conducted?
This trial has 5 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05484206's enrollment target sits among peer trials
144 16th of 53 higher than 38 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
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FMT in Cirrhosis and Hepatic Encephalopathy
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