The Safety and Efficacy of PD-1 Antibody Combined With Pegylated Interferon-α Therapy to Promote the Clinical Cure in Nucleoside (Acid) Analogues-suppressed Chronic Hepatitis B Patients: A Protocol for the Prospective Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- The rate of HBsAg loss at 24 weeks and 48 weeks.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Peg-IFNα group
180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
Intervention: Peg-IFNα-2b (Drug)
Peg-IFNα group
180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
Intervention: NAs (Drug)
PD-1 antibody group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs
Intervention: Sintilimab (Drug)
PD-1 antibody group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs
Intervention: NAs (Drug)
PD-1 antibody combined Peg-IFNα group
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
Outcomes
Primary Outcomes
The rate of HBsAg loss at 24 weeks and 48 weeks.
Time Frame: 48 weeks
Evaluate the level of HBsAg at 24 weeks and 48 weeks.
Incidence of treatment-emergent adverse events/serious adverse events
Time Frame: 48 weeks
Evaluate the treatment-emergent adverse events/serious adverse events
Secondary Outcomes
- The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks.(48 weeks)
- Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks.(48 weeks)
- The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks(48 weeks)
- The rate of HBsAb positive at 24 weeks and 48 weeks.(48 weeks)
- The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks.(48 weeks)
- The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks.(48 weeks)