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RECRUITING
NCT06092333
PHASE2

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

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

View on ClinicalTrials.gov

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.

Official title: A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-31

Completion Date

2028-08-31

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

VIR-2218 and peginterferon alfa-2a

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

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States