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New treatment option for Chronic Hepatitis B
Official title VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B
ClinicalTrials.gov ID: NCT06092333
What this study is testing
What is VIR-2218 and peginterferon alfa-2a?
VIR-2218 and peginterferon alfa-2a is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for chronic hepatitis b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age \>=18-65 years
- HBsAg positive with a level \<2,000 IU/mL at the time of screening
- Hepatitis B e antigen negative
- HBV DNA levels \<10,000 IU/mL on two occasions at least 24 weeks apart with the second being at time of screening
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- For women of childbearing potential, inability, or unwillingness to use highly effective contraception during study drug dosing and for an additional...
- For males of reproductive potential: Unable or unwilling to use condoms consistently in addition to female partner using another adequate...
- Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product
- Current use of oral theophylline and methadone
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age \>=18-65 years
- HBsAg positive with a level \<2,000 IU/mL at the time of screening
- Hepatitis B e antigen negative
- HBV DNA levels \<10,000 IU/mL on two occasions at least 24 weeks apart with the second being at time of screening
- 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
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- 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.
- 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...
- Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product
- Current use of oral theophylline and methadone
- Any treatment for HBV within the last 24 weeks
- Prior exposure to a siRNA
- Co-infection with HDV as defined by the presence of anti-HDV in serum.
- Co-infection with HCV as defined by the presence of anti-HCV and HCV RNA in serum.
- Co-infection with HIV as defined by the presence of anti-HIV in serum
- Cirrhosis either diagnosed by a prior liver biopsy at any time or, if not available, by a transient elastography score \>13 kPa
- 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...
- 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
- Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency)
- A history of solid organ or bone marrow transplant
- 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.
- 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...
- eGFR \ 1.3 mg/dl
- Platelet count \<90 mm\^3/dL
- Hgb \<12 g/dL for males and \<11 g/dL for females
- White Blood cell count \< 2500 cells/mm\^3
- Neutrophil count \< 1500 cell/mm\^3 (or \< 1000 cell/mm\^3 if considered a physiological variant in a subject of African descent)
- 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...
- 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).
- 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)...
- Use of another investigational agent within 90 days of screening
- Use of any prohibited immunosuppressants (except short term use of prednisone as a steroid burst [\<= 1 week of use]) or cytotoxic medications
- Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study.
- Inability of subject to understand and the unwillingness to sign a written informed consent document
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.