A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis B

Korábbi kezelés

• Treatment with interferon or pegylated interferon within 12 weeks prior to first use of investigational product or planned treatment with interferon or pegylated interferon during the trial
• Use of immunosuppressants within 6 months prior to first use of investigational product
• Treatment with corticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to first use of investigational product

Más betegség

• Clinically important chronic diseases other than chronic hepatitis B that, in the opinion of the investigator, make the patient unsuitable for participation in the study

Laborértékek

• Laboratory indicators or symptoms meet one or more of the following: 1) blood phosphorus <0.65 mmol/L; 2) serum albumin <35 g/L; 3) total bilirubin> 1.5 × ULN; 4) hemoglobin <90 g/L; 5) international normalized ratio of prothrombin time ≥ 1.5; 6) ascites, varicose vein bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure; 7) platelet count <90 × 109/L; INR 8) absolute neutrophil count <1.2 × 109/L; 9) serum creatinine> 1.5 × ULN or creatinine clearance <50 mL/min/1.73m2; imaging findings showing cirrhosis or liver space-occupying lesions (except liver cysts or hemangiomas)

• Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures;
• Male or female, age 18-65 (including thresholds)
• Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months)
• Subjects receiving antiviral therapy with a single nucleotide analogue such as tenofovir fumarate (TAF), tenofovir amitidine (TMF), tenofovir disotil fumarate (TDF), or entecavir (ETV) and HBV DNA<100 IU/mL within 28 days prior to first dose of investigational product
• HBeAg negative within 28 days prior to first use of investigational product
• HBsAg>0.05 IU/mL and HBsAg<100 IU/mL within 28 days prior to first use of investigational product