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

NCT06092333 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

VIR-2218 and peginterferon alfa-2a

(VIR-2218) administered as a lead-in followed by combination with peginterferon alfa-2a

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Marc G Ghany, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2028-02-29
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06092333 on ClinicalTrials.gov