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Completed

NCT Number: NCT05612581

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigative Site, Clichy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIR-3434

Drug

VIR-3434 given by subcutaneous injection

Other names: Tobevibart

VIR-2218

Drug

VIR-2218 given by subcutaneous injection

Other names: Elebsiran

TDF

Drug

TDF given orally

PEG-IFNα

Drug

PEG-IFNα given by subcutaneous injection

Primary outcomes

  1. 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

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

    Time frame: Up to 96 weeks

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

    Time frame: Up to 48 weeks

  3. 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

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

    Time frame: Up to 96 weeks

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

    Time frame: Up to 96 weeks

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

    Time frame: Up to 96 weeks

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

    Time frame: Up to 96 weeks

  8. 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

  9. 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

    Time frame: Up to 96 weeks

  10. STRIVE: Proportion of Participants With HBsAg Loss (<0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment

    Time frame: Up to 72 weeks

  11. 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

    Time frame: Up to 96 weeks

  12. STRIVE: For HBeAg-positive Participants: Proportion of Participants With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion

    Time frame: Up to 72 weeks

  13. STRIVE: Incidence and Titers of Anti-drug Antibodies (ADA; if Applicable) to VIR-3434

    Time frame: Up to 96 weeks

  14. STRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study

    Time frame: Up to 96 weeks

  15. STRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ) Across Timepoints in the Study

    Time frame: Up to 96 weeks

  16. STRIVE: Proportion of Participants Achieving ALT ≤ ULN Across Timepoints in the Study

    Time frame: Up to 96 weeks

  17. 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

    Time frame: Up to 92 weeks

  18. THRIVE: Proportion of Participants Achieving HBsAg Loss (< 0.05 IU/mL) at End of Treatment and at 24 Weeks Post-end of Treatment

    Time frame: Up to 44 weeks

  19. THRIVE: Proportion of Participants Achieving Sustained Suppression of HBV DNA (< LLOQ) After Discontinuation of All Treatment at 24 Weeks and at 48 Weeks

    Time frame: Up to 68 weeks

  20. THRIVE: Incidence and Titers of ADA (if Applicable) to VIR-3434

    Time frame: Up to 92 weeks

  21. THRIVE: Mean Change in Serum HBsAg Level From Baseline Across Timepoints in the Study

    Time frame: Up to 92 weeks

  22. THRIVE: Proportion of Participants Achieving HBV DNA (< LLOQ)

    Time frame: Up to 92 weeks

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study title

A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 10, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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