Efficacy of VTP-300 in Chronic Hepatitis B Infection (NCT05343481) | Clinical Trial Compass
CompletedPhase 2
Efficacy of VTP-300 in Chronic Hepatitis B Infection
Hong Kong, Taiwan121 participantsStarted 2022-09-21
Plain-language summary
This is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations)
✓. BMI ≤35 kg/m2
✓. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
✓. If female, willing not to become pregnant up to 8 weeks after the last dose of study vaccine and up to 5 months after the last dose of nivolumab
✓. If female: Not pregnant or breast feeding and one of the following:
✓. Documented evidence of CHB infection (e.g., HBsAg positive ≥6 months with detectable HBsAg levels at screening; both HBeAg+ and HBeAg- allowed)
✓. Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate) or besifovir for at least 6 months before screening
✓. HBV-DNA viral load ≤ 1,000 IU/mL
Exclusion criteria
✕. Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the study requirements
✕. HIV antibody positive and active hepatitis C (antibody positive and then DNA positive)
✕. Co-infection with hepatitis D virus (HDV)
✕. Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to Day 0 (Metavir activity grade A4 and stage F4; Ishak stages 5 - 6).
✕. In the absence of a documented liver biopsy, either 1 of the following (not both):
✕. ALT \>3 x ULN, or INR \>1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin \<3.2 g/dL, direct bilirubin \>1.5 x ULN, platelet count \<100,000/µL.
✕. A history of liver decompensation (e.g., ascites, encephalopathy or variceal haemorrhage)