A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TVAX-008 Injection in Treated Patients With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HBsAg negative conversion rate
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of TVAX-008 Injection in a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial in NAs-treated subjects with chronic hepatitis B. 80 subjects are planned to be enrolled in this study and divided into 2 groups. After a screening period of no more than 4 weeks, eligible subjects will be randomly assigned to enter the double-blind treatment period according to the ratio of 1:1, and receive TVAX-008 injection or placebo in combination with NAs for 24 weeks. At the end of the double-blind treatment period, subjects with HBsAg negative and HBsAg>100 mIU/mL continued to be followed up to Week 73; subjects with HBsAg not negative or HBsAg negative but HBsAg ≤100 mIU/mL entered the open-label treatment period and received TVAX-008 injection combined with NAs for 24 weeks, and continued to be followed up for 24 weeks after the end of the open-label treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary signing of the informed consent form, understanding of the study and willingness to follow and ability to complete all trial procedures;
- •Male or female, age 18-65 (including thresholds)
- •Clinically diagnosed chronic hepatitis B (HBsAg positive serum ≥6 months)
- •Subjects receiving antiviral therapy with a single nucleotide analogue such as tenofovir fumarate (TAF), tenofovir amitidine (TMF), tenofovir disotil fumarate (TDF), or entecavir (ETV) and HBV DNA<100 IU/mL within 28 days prior to first dose of investigational product
- •HBeAg negative within 28 days prior to first use of investigational product
- •HBsAg>0.05 IU/mL and HBsAg<100 IU/mL within 28 days prior to first use of investigational product
排除标准
- •Clinically important chronic diseases other than chronic hepatitis B that, in the opinion of the investigator, make the patient unsuitable for participation in the study
- •Laboratory indicators or symptoms meet one or more of the following: 1) blood phosphorus <0.65 mmol/L; 2) serum albumin <35 g/L; 3) total bilirubin> 1.5 × ULN; 4) hemoglobin <90 g/L; 5) international normalized ratio of prothrombin time ≥ 1.5; 6) ascites, varicose vein bleeding, hepatorenal syndrome, hepatic encephalopathy or liver failure; 7) platelet count <90 × 109/L; INR 8) absolute neutrophil count <1.2 × 109/L; 9) serum creatinine> 1.5 × ULN or creatinine clearance <50 mL/min/1.73m2; imaging findings showing cirrhosis or liver space-occupying lesions (except liver cysts or hemangiomas)
- •Treatment with interferon or pegylated interferon within 12 weeks prior to first use of investigational product or planned treatment with interferon or pegylated interferon during the trial
- •Use of immunosuppressants within 6 months prior to first use of investigational product
- •Treatment with corticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to first use of investigational product
研究组 & 干预措施
TVAX-008
TVAX-008
干预措施: TVAX-008 (Drug)
placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
HBsAg negative conversion rate
时间窗: week37
HBsAg negative conversion rate
次要结局
未报告次要终点