Overview
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.
Eligibility
Inclusion Criteria:
- 18 - 65 years old;
- Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
- Treatment with NAs (ETV, TDF or TAF)at least 1 years and continue NAs therapy during screening;
- HBV DNA and HBeAg turn negative after NAs treatment;
- HBsAg ranged 200-1000 IU/ml.
Exclusion Criteria:
- Cirrhosis;
- 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;
- History of or suspicion of hepatocellular carcinoma
- Patients received interferon therapy within 12 months;
- Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
- Alcohol or drug abuse/dependence;
- Investigator judges that the participants are not suitable for this study.