Actively Recruiting
VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
50
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Positive hepatitis B surface antigen (HBsAg) level less than 2,000 IU/mL at screening
- Hepatitis B e antigen negative
- Hepatitis B virus (HBV) DNA levels less than 10,000 IU/mL on two occasions at least 24 weeks apart, including screening
- Alanine aminotransferase (ALT) level less than or equal to 2 times upper limit of normal, confirmed on two occasions at least 24 weeks apart
You will not qualify if you...
- Pregnancy or breastfeeding
- Women of childbearing potential not using effective contraception during treatment and 24 weeks after
- Men not using condoms plus partner not using contraception during treatment and 24 weeks after
- Allergic or hypersensitive to siRNA, oligonucleotide, GalNAc, or interferon products
- Current use of oral theophylline or methadone
- Any HBV treatment within the last 24 weeks
- Prior exposure to siRNA treatment
- Co-infection with hepatitis D virus, hepatitis C virus, or HIV
- Cirrhosis diagnosed by biopsy or liver elastography over 13 kPa
- Decompensated liver disease or history of serious liver complications
- Hepatocellular carcinoma or liver masses suggestive of cancer
- Other liver diseases like hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, or alpha-1-antitrypsin deficiency
- History of solid organ or bone marrow transplant
- Use of more than 10 mg daily prednisone or biologics within 3 months prior
- Significant systemic illnesses such as heart failure, kidney failure, poorly controlled diabetes, or chronic pancreatitis
- Reduced kidney function (eGFR below 60 ml/min) or elevated serum creatinine
- Low platelet count, hemoglobin, white blood cell count, or neutrophil count
- Active substance abuse or psychiatric conditions affecting participation
- Recent history of cancer or immune-mediated diseases
- Use of other investigational agents within 90 days
- Use of prohibited immunosuppressants or cytotoxic medications
- Conditions preventing study follow-up
- Inability or unwillingness to give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
E
Elenita M Rivera, R.N.
CONTACT
M
Marc G Ghany, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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