RECRUITING

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

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Conditions

Hepatic ImpairmentCirrhosissiRNAMonoclonal antibodyHDVCompensated CirrhosisDecompensated Cirrhosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-21
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05484206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be ≥18 to ≤70 years of age at screening
  2. * Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2
  3. * All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation
  1. * 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
  2. * Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)
  3. * 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

Contacts and Locations

Study Locations (Sites)

Inland Empire Clinical Trials
Rialto, California, 92377
United States
Orange County Research Center
Tustin, California, 92790
United States
CenExel Research Centers of America
Hollywood, Florida, 33024
United States
Floridian Clinical Research
Miami Lakes, Florida, 33016
United States
Texas Liver Institute
San Antonio, Texas, 78215
United States

Collaborators and Investigators

Sponsor: Vir Biotechnology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-21
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-09-21
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • siRNA
  • Monoclonal antibody
  • HDV
  • Compensated Cirrhosis
  • Decompensated Cirrhosis

Additional Relevant MeSH Terms

  • Hepatic Impairment
  • Cirrhosis