Miami Lakes, FLNCT05484206Now EnrollingIRB Ready

Hepatic Impairment Clinical Trial in Miami Lakes, FL

Access cutting-edge hepatic impairment treatment through this clinical trial at a research site in Miami Lakes. Study-provided care at no cost to qualified participants.

Sponsored by Vir Biotechnology, Inc.

Quick Self-Assessment

See if you qualify for this Miami Lakes location

Preparing your pre-screening questions…

Expert Care in Miami Lakes

Access hepatic impairment specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hepatic impairment treatment provided free

Apply for This Miami Lakes Location

Check if you qualify for this hepatic impairment clinical trial in Miami Lakes, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami Lakes

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami Lakes site if eligible
  4. 4Begin participation

About This Hepatic Impairment Study in Miami Lakes

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.

Sponsor: Vir Biotechnology, Inc.

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami Lakes?

Yes, this clinical trial (NCT05484206) has an active research site in Miami Lakes, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatic Impairment Treatment Options in Miami Lakes, FL

If you're searching for hepatic impairment treatment options in Miami Lakes, FL, this clinical trial (NCT05484206) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami Lakes research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hepatic impairment specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatic impairment clinical trials near you to find additional studies recruiting in your area.

More Interstitial Cystitis Trials in Miami Lakes, FL

See all interstitial cystitis clinical trials recruiting in Miami Lakes — not just this study.

Browse Interstitial Cystitis Trials in Miami Lakes →

Browse More Trials by Condition

Interstitial Cystitis TrialsMyalgic Encephalomyelitis TrialsAll Conditions →

Ready to Join in Miami Lakes?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Miami Lakes, FL