A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

Vir Biotechnology, Inc.33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

VIR-3434DRUG

VIR-3434 given by subcutaneous injection

VIR-2218DRUG

VIR-2218 given by subcutaneous injection

TDFDRUG

TDF given orally

PEG-IFNα

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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

Locations (15)

Investigative Site

Clichy, France

Investigative Site

Nice, France

Investigative Site

Rennes, France

Outcomes

Primary Outcomes

STRIVE and THRIVE: Proportion of Participants Achieving Suppression of HBV DNA (< LLOQ) With HBsAg Loss (< 0.05 IU/mL) at the End of Treatment

Time frame: Up to 48 weeks

Secondary Outcomes

STRIVE and THRIVE: Proportion of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Up to 96 weeks

STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at End of Treatment

Time frame: Up to 48 weeks

STRIVE and THRIVE: Proportion of Participants With Serum HBsAg ≤ 10 IU/mL at 24 Weeks Post-end of Treatment

Time frame: Up to 72 weeks

STRIVE and THRIVE: Serum HBsAg Levels and Change From Baseline Across Timepoints in the Study

Time frame: Up to 96 weeks

STRIVE and THRIVE: Serum HBsAg Level at Nadir During the Study

Time frame: Up to 96 weeks

STRIVE and THRIVE: Time to Achieve Nadir of Serum HBsAg During the Study

Time frame: Up to 96 weeks

STRIVE and THRIVE: Time to Achieve Serum HBsAg Loss (< 0.05 IU/mL)

Time frame: Up to 96 weeks

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

Time frame: Up to 76 weeks

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.