Chronic hepatitis B
Conditions
Interventions
Group A:Autologous gamma delta T cells in combination with antiviral therapy of nucleoside (acid) analogues
Group B:Antiviral therapy of nucleoside (acid) analogues
Sponsors
Hangzhou xixi hospital (The Sixth People's Hospital of Hangzhou)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, male or female (signed the informed consent form); 2. Patients indicated for antiviral therapy with HBeAg-positive chronic hepatitis B received continuous treatment of nucleoside (acid) analogues for more than 2 years and no virological breakthrough occured; 3. The level of serum e antigen in 1-10 PEI/ml and e antibody was negative for more than 12 months; 4. Be willing to accept the original antiviral treatment plan for more than 1 years unless the attending physician believed that the original plan is not suitable for patients.
Exclusion criteria
Exclusion criteria: 1. Complicated with active hepatitis A, C, D and E infection;history of chronic liver disease except hepatitis; 2. decompensated cirrhosis or liver function failure; 3. Active bleeding; 4. Major organ dysfunction; 5. Coagulation disorders; 6. Pregnant women; 7. Being used immunosuppressive drugs or long term used of immunosuppressive agents after organ transplantation 8. The alcohol/drug addict without withdrawal; 9. Other indications that the patient is not suitable for treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg seroconversion rate at week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg loss rate at week 48;Positive transfer rate of HBeAb at week 48;safety evaluation;determinants for therapeutic effect; | — |
Countries
China
Contacts
Public ContactZHE YU
Hangzhou xixi hospital (The Sixth People's Hospital of Hangzhou)
Outcome results
None listed