Pure Global AI
NCT06092333Not yet recruiting

VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
VIR-2218 and peginterferon alfa-2a
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funder
National Institutes of Health Clinical Center (CC)
Location
Bethesda, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 10, 2023
End date
Jun 30, 2026
Enrollment
50 participants
Primary outcome

Decline in log quantitative HBsAg level

Summary

Background:
 
 Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die
 each year from cirrhosis, liver cancer, and related issues. Treatment options are limited.
 
 Objective:
 
 To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection.
 
 Eligibility:
 
 People aged 18 to 65 years with mild or inactive HBV infection.
 
 Design:
 
 Participants will be screened. They will have blood tests and an eye exam. They will have
 imaging scans of the liver to check the health of the liver.
 
 Participants will be in the study for over 2 years.
 
 VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh.
 Participants will come to the clinic to receive this injection once a month for 6 months.
 
 Peginterferon is also injected under the skin. Participants will have this shot once a week
 for 6 months. They may either inject themselves at home or come to the clinic to get the
 injections.
 
 Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just
 the peginterferon for 3 months.
 
 Participants will have two 3-day stays in the hospital. Tests will include:
 
 Liver biopsy. A sample of tissue will be taken from their liver. After the procedure,
 participants will lie on their right side for 2 hours and then on their back for 4 hours.
 
 Fine needle aspiration. A small needle will be used to collect cells from the liver.
 
 After the last injection of peginterferon, follow-up visits will continue in the outpatient
 clinic every 4 to 12 weeks.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06092333
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06092333 through Pure Global AI's free database. This Phase 2 trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and is currently Not yet recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.