VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B - Trial NCT06092333
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.
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Study Focus
Sponsor & Location
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
Timeline & Enrollment
Phase 2
Dec 10, 2023
Jun 30, 2026
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
Data Source
ClinicalTrials.gov
NCT06092333
Non-Device Trial