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
概览
- 阶段
- 不适用
- 干预措施
- Peg-IFNα-2b
- 疾病 / 适应症
- Chronic Hepatitis B
- 发起方
- Beijing 302 Hospital
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The rate of HBsAg loss at 24 weeks and 48 weeks.
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Peg-IFNα group
180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
干预措施: Peg-IFNα-2b
Peg-IFNα group
180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs
干预措施: NAs
PD-1 antibody group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs
干预措施: Sintilimab
PD-1 antibody group
1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs
干预措施: NAs
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
结局指标
主要结局
The rate of HBsAg loss at 24 weeks and 48 weeks.
时间窗: 48 weeks
Evaluate the level of HBsAg at 24 weeks and 48 weeks.
Incidence of treatment-emergent adverse events/serious adverse events
时间窗: 48 weeks
Evaluate the treatment-emergent adverse events/serious adverse events
次要结局
- 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)