Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
Brief summary
This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy
Interventions
Sponsors
Vir Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ages 18 - \<66 years * Chronic HBV infection for \>/= 6 months * On NRTI therapy for \>/= 2 months at the time of screening
Exclusion criteria
* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation * Significant fibrosis or cirrhosis * History or evidence of drug or alcohol abuse * History of chronic liver disease from any cause other than chronic HBV infection * History of hepatic decompensation * History of anaphylaxis * History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 * History of immune complex disease * History of known contraindication to any interferon product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to 72 weeks |
| Proportion of participants with serious adverse events (SAEs) | Up to 72 weeks |
| Proportion of participants with hepatitis B surface antigen (HBsAg) loss (defined as undetectable HBsAg) at end of treatment | Up to 48 weeks |
| Proportion of participants with HBsAg loss (defined as undetectable HBsAg) at 24 weeks post-end of treatment | Up to 72 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For hepatitis B e-antigen (HBeAg)-positive participants: Proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint | Up to 110 weeks | — |
| For HBeAg-positive participants: Time to HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion | Up to 110 weeks | — |
| Cmax | Up to 110 weeks | — |
| AUClast | Up to 110 weeks | — |
| t1/2 | Up to 110 weeks | — |
| CL/F | Up to 110 weeks | — |
| Number of participants with incidence and titers of anti-drug antibody (ADA) (if applicable) to VIR-3434 | Up to 110 weeks | — |
| Time to achieve serum HBsAg loss | Up to 110 weeks | — |
| Proportion of participants meeting criteria for NRTI retreatment | Up to 110 weeks | — |
| Proportion of participants achieving undetectable HBsAg and sustained suppression of HBV DNA [below the LLOQ, target not detected (TND)] >/= 24 weeks after discontinuation of all treatment, including NRTIs | Up to 110 weeks | — |
| Proportion of participants with serum HBsAg < 10 IU/mL at end of treatment | Up to 48 weeks | — |
| Proportion of participants with serum HBsAg < 10 IU/mL at 24 weeks post-end of treatment | Up to 72 weeks | 48 weeks treatment + 24 weeks post-end of treatment |
| Proportion of participants with anti-HBs seroconversion | Up to 110 weeks | — |
| Time to achieve nadir of serum HBsAg | Up to 110 weeks | — |
| Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation | Up to 60 weeks | — |
| Absolute serum HBsAg and change from baseline across all timepoints in the study | Up to 110 weeks | — |
| Nadir and maximum reduction of serum HBsAg from baseline | Up to 110 weeks | — |
| Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification (LLOQ) for >= 24 weeks after discontinuation of all treatment, including NRTIs) | Up to 110 weeks | — |
Countries
Canada, Germany, Hong Kong, Malaysia, Moldova, New Zealand, Romania, South Korea, Taiwan, Ukraine, United Kingdom, United States
Outcome results
None listed