Chronic hepatitis B
Conditions
Interventions
experimental group:TVAX-008 Injection
placebo group:placebo
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures; 2.Male or female, age 18~65 years old (including limits); 3.Patients with clinically confirmed chronic hepatitis B (HBsAg positive >=6 months) or treatment-naive HBV infection are defined as follows: a) CHB patients who have previously received siRNA/ASO anti-hepatitis B therapy: received small nucleic acid drug (siRNA or ASO) anti-hepatitis B therapy, the small nucleic acid drug has been discontinued before the use of the investigational product, and HBV DNA 100 IU/mL within 28 days before the first use of the investigational product; treatment-naive HBV infection patients: have not received systematic anti-HBV therapy (including interferons, NAs, Chinese herbal medicines with definite anti-HBV activity and other drugs) within 6 months before screening, have not received siRNA or ASO anti-HBV therapy at any time before, and HBV DNA 2000 IU/mL within 28 days before the first use of the investigational product; 4.Hepatitis B e antigen (HBeAg) negative within 28 days prior to first use of investigational product; 5.HBsAg>0.05 IU/mL and HBsAg<100 IU/mL within 28 days prior to first use of investigational product; 6.Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=5×ULN within 28 days prior to first dose of investigational product; 7.Antinuclear antibodies (ANA) negative, or abnormal but not supportive of diagnosis of autoimmune liver disease in investigator judgment; 8.No history of cirrhosis and liver stiffness value (LSM) 9.0 kPa within 6 months prior to screening; 9.Female subjects must have a negative serum pregnancy test, must not be lactating, or be confirmed to be postmenopausal. Subjects of childbearing potential (male or female) must be willing to use highly effective contraception from signing informed consent until the end of the studySubjects of childbearing potential (male or female) must be willing to use highly effective contraception from signing informed consent until the end of the study; 10.Subjects of childbearing potential (male and female) must be willing to use highly effective contraception from the time of signing the informed consent form until the end of the study.
Exclusion criteria
Exclusion criteria: 1.Clinically important chronic diseases other than chronic hepatitis B that, in the opinion of the investigator, make the subject unsuitable for participation in the study; 2.Laboratory indicators or symptoms meet one or more of the following: 1) blood phosphorus 1.5×ULN; 4) hemoglobin =1.5; 6) ascites, varicose vein bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure, etc. 7) Platelet count 1.5×ULN or creatinine clearance =10%] or hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 12.History of severe prior drug or food allergies; 13.Past or current diagnosis of mental illness or major depression; 14.Participation in clinical trials of other investigational drugs or biologics, medical devices, vaccines within 30 days prior to the first use of the investigational productParticipation in clinical trials of other investigational drugs or biologics, medical devices, vaccines within 30 days prior to the first use of the investigational product; 15.Subjects who have taken the investigational drug TVAX-008 Injection within the previous 6 months; 16.The investigator considers it inappropriate to participate in this trial due to other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative conversion rate at week 49;HBsAg negative conversion rate at 24 weeks after discontinuation of NAs [only for the population of subjects who met the discontinuation criteria for NAs at Week 49 (for 6 doses)/Week 61 (for 9 doses); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >= 0.5 log10, >= 1 log10, >= 2 log10 HBsAg reduction from baseline at Week 25, Week 37, Week 49, Week 61, Week 73, Week 85 (9 doses only);;HBsAg reduction from baseline at Week 25, Week 37, Week 49, Week 61, Week 73, Week 85 (9 doses only);HBsAg negative conversion rate at week 25, week 37, week 61, week 73, week 85 (only 9 doses);HBsAg seroconversion rate at week 25, week 37, week 49, week 61, week 73, week 85 (only 9 doses);Time from randomization to conversion of subjects to HBsAb;Time from randomization to HBsAg seroconversion;Change from baseline in HBsAb levels at Week 25, Week 37, Week 49, Week 61, Week 73, Week 85 (9 doses only);HBsAb positive conversion rate at week 25, week 37, week 49, week 61, week 73, week 85 (only 9 doses);Changes from baseline in other hepatitis B related parameters [including HBV DNA, hepatitis B virus RNA, hepatitis B core related antigen] at Week 25, Week 37, Week 49, Week 61, Week 73, Week 85 (only;Proportion of subjects with HBsAg negative and HBsAb positive (persistent positive and transition to positive) at Week 25, Week 37, Week 49, Week 61, Week 73, Week 85 (only 9 doses); | — |
Countries
China
Contacts
Public ContactHoujinlin
Southern Medical University Southern Hospital
Outcome results
None listed