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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05612581
Other study ID # VIR-MHB1-V200
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 10, 2023
Est. completion date March 2027

Study information

Verified date February 2024
Source Vir Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.


Description:

VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment. VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date March 2027
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 66 Years
Eligibility Inclusion Criteria: - Male or female ages 18 or older - Chronic HBV infection for >/= 6 months - Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation - STRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and = 5x ULN - THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA = 2,000 IU/mL, ALT = ULN Exclusion Criteria: - Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation - History of clinically significant liver disease from non-HBV etiology - History or current evidence of hepatic decompensation - Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV). - History or clinical evidence of alcohol or drug abuse - STRIVE and THRIVE: Significant fibrosis or cirrhosis - STRIVE and THRIVE: History of immune complex disease - STRIVE and THRIVE: History of autoimmune disorder - STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 - STRIVE: Prior NRTI or PEG-IFN therapy - STRIVE: History of known contraindication to any interferon product - THRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy

Study Design


Intervention

Drug:
VIR-3434
VIR-3434 given by subcutaneous injection
VIR-2218
VIR-2218 given by subcutaneous injection
TDF
TDF given orally
PEG-IFNa
PEG-IFNa given by subcutaneous injection

Locations

Country Name City State
France Investigative Site Clichy
France Investigative Site Nice
France Investigative Site Rennes
France Investigative Site Toulouse
Hong Kong Investigative Site Hong Kong Sha Tin
Hong Kong Investigative Site Hong Kong
Korea, Republic of Investigative Site Busan
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Yangsan
Moldova, Republic of Investigative Site Chisinau
Romania Investigative Site Bucharest
United Kingdom Investigative Site Glasgow
United Kingdom Investigative Site London
United Kingdom Investigative Site London
United Kingdom Investigative Site Manchester

Sponsors (1)

Lead Sponsor Collaborator
Vir Biotechnology, Inc.

Countries where clinical trial is conducted

France,  Hong Kong,  Korea, Republic of,  Moldova, Republic of,  Romania,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary STRIVE and THRIVE: Proportion of participants achieving suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at the end of treatment Up to 72 weeks
Secondary STRIVE and THRIVE: Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) Up to 96 weeks
Secondary STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at end of treatment Up to 48 weeks
Secondary STRIVE and THRIVE: Proportion of participants with serum HBsAg = 10 IU/mL at 24 weeks post-end of treatment Up to 72 weeks
Secondary STRIVE and THRIVE: Serum HBsAg levels and change from baseline across timepoints in the study Up to 96 weeks
Secondary STRIVE and THRIVE: Serum HBsAg level at nadir during the study Up to 96 weeks
Secondary STRIVE and THRIVE: Time to achieve nadir of serum HBsAg during the study Up to 96 weeks
Secondary STRIVE and THRIVE: Time to achieve serum HBsAg loss (< 0.05 IU/mL) Up to 96 weeks
Secondary STRIVE and THRIVE: Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment Up to 76 weeks
Secondary STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit Up to 96 weeks
Secondary STRIVE: Proportion of participants with HBsAg loss (<0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment Up to 72 weeks
Secondary STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit Up to 96 weeks
Secondary STRIVE: For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion Up to 72 weeks
Secondary STRIVE: Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434 Up to 96 weeks
Secondary STRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study Up to 96 weeks
Secondary STRIVE: Proportion of participants achieving HBV DNA (< LLOQ) across timepoints in the study Up to 96 weeks
Secondary STRIVE: Proportion of participants achieving ALT = ULN across timepoints in the study Up to 96 weeks
Secondary THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at 48 weeks Up to 92 weeks
Secondary THRIVE: Proportion of participants achieving HBsAg loss (< 0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment Up to 44 weeks
Secondary THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at 48 weeks Up to 68 weeks
Secondary THRIVE: Incidence and titers of ADA (if applicable) to VIR-3434 Up to 92 weeks
Secondary THRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study Up to 92 weeks
Secondary THRIVE: Proportion of participants achieving HBV DNA (< LLOQ) Up to 92 weeks
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