Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 (NCT05484206)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Inland Empire Clinical Trials — Rialto, California
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Inland Empire Clinical Trials — Rialto, California
- Orange County Research Center — Tustin, California
- CenExel Research Centers of America — Hollywood, Florida
- Floridian Clinical Research — Miami Lakes, Florida
- Texas Liver Institute — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: (909) 883-2999
Email: abenavides@ieliverfoundation.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatic Impairment
- A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144 — Mesa, Arizona
- A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment — Lake Forest, California
- A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease — Miami Lakes, Florida
- A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234 — Chandler, Arizona
- Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI) — Orlando, Florida
- Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease — Indianapolis, Indiana
Explore by condition: All Hepatic Impairment clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.