VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
Status:
Not yet recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)