Study of VIR-2218, VIR-3434, And/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection
Phase 2
Active, not recruiting
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT04856085
- Lead Sponsor
- Vir Biotechnology, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 244
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total Cohort 5a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks Cohort 1d (VIR-3434 + PEG-IFNα) PEG-IFNα Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα) PEG-IFNα Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks Cohort 1a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα) PEG-IFNα Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks Cohort 3a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks Cohort 5a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks Cohort 4a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks Cohort 6a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks Cohort 7a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks Cohort 8a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα) VIR-2218 Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks Cohort 1a (VIR-2218 + VIR-3434) VIR-2218 Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total Cohort 2a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total Cohort 3a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks Cohort 4a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks Cohort 1b (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for 44 weeks Cohort 6a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks Cohort 7a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks Cohort 8a (VIR-2218 + VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks Cohort 2b (VIR-3434) VIR-3434 Participants will receive multiple doses of VIR-3434 for 20 weeks Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα) VIR-3434 Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks Cohort 1d (VIR-3434 + PEG-IFNα) VIR-3434 Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to achieve serum HBsAg loss Up to 110 weeks Proportion of participants meeting criteria for NRTI retreatment Up to 110 weeks Absolute serum HBsAg and change from baseline across all timepoints in the study Up to 110 weeks 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 Tmax Up to 110 weeks Nadir and maximum reduction of serum HBsAg from baseline Up to 110 weeks Clast Up to 110 weeks Tlast Up to 110 weeks t1/2 Up to 110 weeks λz Up to 110 weeks Cmax Up to 110 weeks AUCinf Up to 110 weeks AUClast 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 %AUCexp Up to 110 weeks Vz/F 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 Proportion of participants meeting criteria for nucleotide reverse transcriptase inhibitors (NRTI) discontinuation Up to 60 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 anti-HBs seroconversion Up to 110 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
Time to achieve nadir of serum HBsAg Up to 110 weeks
Trial Locations
- Locations (1)
Investigative Site
🇬🇧Manchester, United Kingdom