A platform study to evaluate investigational therapies in chronic hepatitis B infection

A platform study evaluating the efficacy and safety of investigational therapies in participants with chronic hepatitis B infection (PREVAIL)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29337285

Enrollment

150

Registered

2022-09-28

Start date

2022-10-18

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B infection Infections and Infestations

Interventions

Sub-Protocol A (STRIVE): Participants will receive combination therapy with VIR-3434, VIR-2218, PEG-IFNa, and/or TD/TDF up to 48 weeks total Assigned interventions: Drug: VIR-3434 VIR-3434 given by s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 18 years old and over 2. Chronic HBV infection for >/= 6 months 3. A Body Mass Index (BMI) less than 18 kg/m2 or greater than 35 kg/m2

Exclusion criteria

Exclusion criteria: 1. History or current suspicion of malignancy diagnosed or treated within 5 years 2. Any clinically significant medical or psychiatric condition that may interfere with study intervention, assessment, or compliance with the protocol or otherwise makes the participant unsuitable for participation in the study 3. History or evidence of drug or alcohol abuse 4. History of hepatic decompensation

Design outcomes

Primary

Measure	Time frame
1. Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification [LLOQ]) at 24 weeks after discontinuation of all treatment 2. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at 24 weeks after discontinuation of all treatment 3. Proportion of participants with Hepatitis B surface antigen (HBsAg) loss (<0.05 IU/ml) at the end of treatment 4. Proportion of participants with HBsAg loss (<0.05 IU/ml) at 24 weeks post-end of treatment 5. Mean change in serum HBsAg from baseline across time points in the study STRIVE: 6. Proportion of participants with HBsAg loss (< 0.05 IU/ml) at the end of treatment THRIVE: 7. Proportion of participants with HBsAg loss (<0.05 IU/ml) at the end of treatment All outcomes measured using drawn blood	—

Measure

Time frame

1. Proportion of participants achieving sustained suppression of HBV DNA (< lower limit of quantification [LLOQ]) at 24 weeks after discontinuation of all treatment 2. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at 24 weeks after discontinuation of all treatment 3. Proportion of participants with Hepatitis B surface antigen (HBsAg) loss (<0.05 IU/ml) at the end of treatment 4. Proportion of participants with HBsAg loss (<0.05 IU/ml) at 24 weeks post-end of treatment 5. Mean change in serum HBsAg from baseline across time points in the study STRIVE: 6. Proportion of participants with HBsAg loss (< 0.05 IU/ml) at the end of treatment THRIVE: 7. Proportion of participants with HBsAg loss (<0.05 IU/ml) at the end of treatment All outcomes measured using drawn blood

—

Secondary

Measure	Time frame
1. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study 2. Proportion of participants with serum HBsAg = 10 IU/ml at end of treatment 3. Proportion of participants with serum HBsAg = 10 IU/ml at 24 weeks post-end of treatment 4. Serum HBsAg levels and change from baseline across time points in the study 5. Serum HBsAg level at nadir during the study 6. Time to achieve nadir of serum HBsAg during the study 7. Time to achieve serum HBsAg loss (< 0.05 IU/ml) 8. Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment STRIVE: 9. Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment 10. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment: 10.1. At 24 weeks 10.2. At the F48 Follow-Up visit 11. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/ml) after discontinuation of all treatment: 11.1. At 24 weeks 11.2. At the F48 Follow-Up visit 12. For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion 13. Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434 14. Mean change in serum HBsAg level from baseline across time points in the study 15. Proportion of participants achieving HBV DNA (< LLOQ) across time points in the study 16. Proportion of participants achieving ALT = ULN across time points in the study THRIVE: 9. Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment 10. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment: 10.1. At 24 weeks 10.2. At 48 weeks 11. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU	—

Measure

Time frame

1. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study 2. Proportion of participants with serum HBsAg = 10 IU/ml at end of treatment 3. Proportion of participants with serum HBsAg = 10 IU/ml at 24 weeks post-end of treatment 4. Serum HBsAg levels and change from baseline across time points in the study 5. Serum HBsAg level at nadir during the study 6. Time to achieve nadir of serum HBsAg during the study 7. Time to achieve serum HBsAg loss (< 0.05 IU/ml) 8. Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment STRIVE: 9. Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment 10. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment: 10.1. At 24 weeks 10.2. At the F48 Follow-Up visit 11. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/ml) after discontinuation of all treatment: 11.1. At 24 weeks 11.2. At the F48 Follow-Up visit 12. For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion 13. Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434 14. Mean change in serum HBsAg level from baseline across time points in the study 15. Proportion of participants achieving HBV DNA (< LLOQ) across time points in the study 16. Proportion of participants achieving ALT = ULN across time points in the study THRIVE: 9. Proportion of participants with HBsAg loss (< 0.05 IU/mL) at 24 weeks post-end of treatment 10. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment: 10.1. At 24 weeks 10.2. At 48 weeks 11. Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU

—

Countries

New Zealand

Contacts

Public ContactVir Biotechnology

clinicaltrials@vir.bio+1 415 654 5281

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026