The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT06357806
- Lead Sponsor
- Beijing 302 Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD-1 antibody group NAs 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs PD-1 antibody combined Peg-IFNα group Peg-IFNα-2b 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs Peg-IFNα group Peg-IFNα-2b 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs Peg-IFNα group NAs 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs PD-1 antibody combined Peg-IFNα group NAs 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs PD-1 antibody group Sintilimab 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs PD-1 antibody combined Peg-IFNα group Sintilimab 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
- Primary Outcome Measures
Name Time Method The rate of HBsAg loss at 24 weeks and 48 weeks. 48 weeks Evaluate the level of HBsAg at 24 weeks and 48 weeks.
Incidence of treatment-emergent adverse events/serious adverse events 48 weeks Evaluate the treatment-emergent adverse events/serious adverse events
- Secondary Outcome Measures
Name Time Method 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.
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)
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 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.
Trial Locations
- Locations (1)
the Fifth Medical Center, Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China