NCT05612581CompletedPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 3 Nov 2022
- Start date
- 10 May 2023
- Primary completion date
- 15 Oct 2024
- Lead sponsor
- Vir Biotechnology, Inc.
- Diseases
- Hepatitis B
- NCT number
- NCT05612581
- EU CT number
- 2024-513176-17-00
- EudraCT number
- 2022-002014-16
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 33
- From 10 May 2023 to the primary completion date, 15 Oct 2024
- 10 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or clinical evidence of alcohol or drug abuse
- STRIVE: Prior NRTI or PEG-IFN therapy
- THRIVE: Prior NRTI therapy \< 24 weeks of study or any prior PEG-IFN therapy
Other illness
- 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
- Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
- 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: History of known contraindication to any interferon product
Other
- History or current evidence of hepatic decompensation
- STRIVE and THRIVE: Significant fibrosis or cirrhosis
Who the study is looking for
- 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
Age in the registry: 18 years to 66 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Completed |
| Investigative Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| Investigative Site Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.