This is a multicenter, randomized, placebo-controlled (double-blind design) versus active-controlled (open-label design) Phase I clinical trial evaluating the efficacy and safety of TVAX-008 injection in subjects with chronic hepatitis B.
Male or female, aged 18 to 65 years (inclusive);
Clinically diagnosed chronic hepatitis B (serum HBsAg positive ≥6 months);
Subjects with a history of nucleoside (acid) analog anti-hepatitis B therapy lasting ≥6 months until screening, currently receiving antiviral therapy with a single nucleoside (acid) analog [eg, tenofovir fumarate (TAF), amitenofovir (TMF), tenofovir disoform fumarate (TDF) or entecavir (ETV), etc.], and HBV DNA<100 IU/mL within 28 days prior to the first dose of investigational product;
Hepatitis B virus e antigen (HBeAg) negative within 28 days prior to first use of investigational product;
Liver disease caused by other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, hemochromatosis, etc.;
In addition to chronic hepatitis B, clinically important chronic diseases that, in the opinion of the investigator, make the patient unsuitable for participation in the study, including but not limited to thyroid disease requiring clinical intervention or clinically significant thyroid dysfunction, fundus disease (e.g. retinopathy), chronic lung disease with lung dysfunction, history of severe seizures or current use of antiepileptic drugs, immunodeficiency or autoimmune disease;
Blood phosphorus <0.65 mmol/L;
Serum albumin <35 g/L;
Parallel
TVAV-008
DrugTVAV-008 will be administered per 4 weeks
PegIFNα2b
DrugPegIFNα will be administered per week
Placeb
DrugPlacebo will be administered per 4 weeks
Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).
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This trial is not recruiting at the moment. You can still explore other options:
