chronic viral hepatitis B
Conditions
Interventions
Group A:Recombinant lentiviral vector injection for chronic hepatitis B, use 5.0 x 10^7 TU at a time, once a week for three weeks
Group B:Recombinant lentiviral vector injection for chronic hepatitis B, use 1.0 x 10^8 TU at a time, once a week for three weeks
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 - 65 years; 2. Chronic hepatitis B (CHB) defined by a positive HBsAg or HBV DNA (surface antigen of the hepatitis B virus) for at least 6 months according to the guidelines of prevention and treatment for chronic hepatitis B (2019 version); Besides, patients should be diagnosed as a HBeAg positive or HBeAg negative CHB with elevated glutamic-pyruvic transaminase (ALT) or an inactive carrier; 3. No evidence of decompensated liver disease now and before, as well as serum total bilirubin = 35 g/L, platelet count >= 100 x 10^6/mL at screening; 4. Neutrophil count >= 1.2 x 10^6/mL, ALT = 100 g/L and eGFR > 50mL/min at screening; 5. Absence of liver cirrhosis within 12 months confirmed by liver biopsy or no progressive liver fibrosis within 6 months confirmed by transient elastography (TE) or other tests; 6. Negative urine or serum pregnancy test (for women of childbearing potential) prior to the first dose of test drug and agree to contraception during treatment and within 6 months at the end of treatment; 7. Agree to participate in the study and sign the patient informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with alpha-fetoprotein (AFP) >= 50 ng/mL or with evidence of suspected hepatocellular carcinoma or other types of liver cancer; 2. Accompanied by other liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver, non-alcoholic fatty liver, liver cirrhosis, a1 antitrypsin deficiency, Wilson disease; 3. Patients with positive antibody of hepatitis C virus (HCV), hepatitis D virus (HDV), treponema pallidum (TP) or human immunodeficiency virus (HIV); 4. Use of immunosuppressive (except topical or inhaled corticosteroids) therapy or immunomodulatory therapy (including interferon or thymosin) within 6 months before screening and during the treatment; 5. Patients who have used any agents (except topical use) that alter liver enzyme activity (such as inhibitors or inducers of CYP3A4) and P-gp or Bcrp (such as itraconazole, ketoconazole) within 28 days before screening; 6. Allergic to the investigational product or its excipients, multiple food or drug allergies; 7. Active alcohol (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results; 8. Participated in other drug clinical trials within 3 months before participant in this study; 9. Women with ongoing pregnancy or breast-feeding; 10. Patients who are considered by the investigator to be unsuitable to participate in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Incidence of adverse effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with HBsAg loss;The proportion of patients with HBsAg seroconversion;Intrahepatic cccDNA;Serum HBV DNA quatification;Proportion of patients with hepatitis B virus antigen specific T cell immune response;Time of occurrence of hepatitis B virus antigen specific T cell immune response;Activation of CD4+ T cell subsets;Activation of CD8+ T cell subsets;Changes in cytokine expression patterns of CD4+ T cell subsets;Changes in cytokine expression patterns of CD8+ T cell subsets;Number of adverse events;The proportion of patients with HBsAg quantitation declined more than 1 log;The proportion of patients with HBsAg quantitation declined more than 0.5 log; | — |
Countries
China
Contacts
Public ContactHong Wu
Changzhi People's Hospital
Outcome results
None listed