Chronic Hepatitis B
Conditions
Brief summary
This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.
Interventions
Sponsors
Beijing 302 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 - 65 years old; 2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months); 3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening; 4. HBV DNA and HBeAg turn negative after NAs treatment; 5. HBsAg ranged 200-1000 IU/ml.
Exclusion criteria
1. Cirrhosis; 2. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN; 3. History of or suspicion of hepatocellular carcinoma 4. Patients received interferon therapy within 12 months; 5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months; 6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; 7. Alcohol or drug abuse/dependence; 8. Investigator judges that the participants are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events/serious adverse events | 48 weeks | Evaluate the treatment-emergent adverse events/serious adverse events |
| The rate of HBsAg loss at 24 weeks and 48 weeks. | 48 weeks | Evaluate the level of HBsAg at 24 weeks and 48 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks | 48 weeks | Evaluate the level of serum HBsAg at 24 weeks and 48 weeks. |
| The rate of HBsAb positive at 24 weeks and 48 weeks. | 48 weeks | Evaluate the level of serum HBsAb at 24 weeks and 48 weeks. |
| The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks | Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. |
| The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks | Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. |
| The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks | Evaluate the level of serum anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. |
| Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks | Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot) |
Countries
China
Outcome results
None listed