New drug combo aims to tame hepatitis b virus
NCT ID NCT06092333
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 7 times
Summary
This study tests two drugs, VIR-2218 and peginterferon, in 50 adults with mild chronic hepatitis B. The goal is to lower the virus level in the blood and improve the body's immune response. Participants receive injections for 6 months and are followed for over 2 years, including liver biopsies and scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age \>=18-65 years 2. HBsAg positive with a level \<2,000 IU/mL at the time of screening 3. Hepatitis B e antigen negative 4. HBV DNA levels \<10,000 IU/mL on two occasions at least 24 weeks apart with the second being at time of screening 5. ALT level \<=2 ULN (using sex-specific cut-offs of normal 35 U/L for males and 25 U/L for females) based on at least two determinations taken at least 24 weeks apart with the second being at time of screening EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy or lactation 2. For women of childbearing potential, inability, or unwillingness to use highly effective contraception during study drug dosing and for an additional 24 weeks after the end of study drug administration. 3. For males of reproductive potential: Unable or unwilling to use condoms consistently in addition to female partner using another adequate contraceptive method to ensure effective contraception with partner during study participation and for an additional 24 weeks after the end of study medication administration. Patients who have underwent surgical sterilization (vasectomy) will still require female partner to utilize an additional adequate contraception method. 4. Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product 5. Current use of oral theophylline and methadone 6. Any treatment for HBV within the last 24 weeks 7. Prior exposure to a siRNA 8. Co-infection with HDV as defined by the presence of anti-HDV in serum. 9. Co-infection with HCV as defined by the presence of anti-HCV and HCV RNA in serum. 10. Co-infection with HIV as defined by the presence of anti-HIV in serum 11. Cirrhosis either diagnosed by a prior liver biopsy at any time or, if not available, by a transient elastography score \>13 kPa 12. Decompensated liver disease as defined by serum bilirubin \>2.5 mg/dL (with direct bilirubin \> 1.5 mg/dL), prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.5 g/dL, or a history of ascites, variceal bleeding or hepatic encephalopathy 13. Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggestive of HCC, or an alpha-fetoprotein level of greater than 500 ng/mL 14. Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency) 15. A history of solid organ or bone marrow transplant 16. Any current medical condition requiring the chronic use of more than 10 mg of prednisone (or its equivalent) daily or biologics (e.g. monoclonal antibody, interferon) within 3 months of screening. 17. Significant systemic illness other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis and diabetes mellitus with poor control (hemoglobin A 1C (HgbA1C \>8.5)), that in the opinion of the investigator may interfere with therapy. 18. eGFR \< 60 ml/min, serum creatinine \> 1.3 mg/dl 19. Platelet count \<90 mm\^3/dL 20. Hgb \<12 g/dL for males and \<11 g/dL for females 21. White Blood cell count \< 2500 cells/mm\^3 22. Neutrophil count \< 1500 cell/mm\^3 (or \< 1000 cell/mm\^3 if considered a physiological variant in a subject of African descent) 23. Active ethanol/drug abuse/psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator's opinion, might interfere with participation in the study. 24. History of malignancy or treatment for a malignancy within the past 3 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin). 25. History of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, (TSH \>10 or \<0.4mU/L) or uncontrolled seizure disorder, as determined by a study physician. 26. Use of another investigational agent within 90 days of screening 27. Use of any prohibited immunosuppressants (except short term use of prednisone as a steroid burst \[\<= 1 week of use\]) or cytotoxic medications 28. Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study. 29. Inability of subject to understand and the unwillingness to sign a written informed consent document
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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