A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- HBV makers
研究概览
简要总结
The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients
详细描述
The 450 patients meeting the entry criteria are divided into 6 groups, the clinical trial procedure is divided into 3 parts, according to the following steps:
Part1 (0-12W):
- The research objects will be grouped according to the principle of a multicenter, randomized, open, parallel controlled clinical trial, 300 cases of cell therapy groups (100 cases with PEG-IFN treatment, LdT treatment for 100 cases, ETV treatment for 100 cases), 150 cases of control groups (PEG-IFN therapy in 50 cases, LdT therapy for 50 cases, ETV treatment for 50 cases).
Part2 (12-36W): 2. Cell therapy groups: enter the HBsAg sensitized dendritic cells activated T cells (HBsAg Pulse DCs-T, HPDCs-T) immune therapy combined with interferon (IFN) or nucleoside analogues treatment (NAs), infusion of HPDC-T every 2 weeks for 1 time, total 12 times. 3. Control groups: antiviral therapy used only (IFN or NAs).
Part3 (36-72W): 4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs cases will continue on treatment with NAs.
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
- None
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
- 否
入选标准
- •serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; HBV DNA loads≥ 104IU/ml(Roche Cobas); Containing the IFN treatment: 2ULN ≤ ALT ≤ 10ULN and TBil ≤ 2ULN; Containing the ETV/LdT treatment: 2ULN ≤ ALT and TBil ≤ 5ULN; All patients have not received antiviral treatment or immunotherapy for the last 6 months.
排除标准
- •superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus; other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis; ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; liver cirrhosis; severe bacterial or fungal infections; a history of diabetes or cardiac disease or hypertension or nephrosis; pregnant women.
结局指标
主要结局
HBV makers
时间窗: 01/01/2014-31/12/2016, total 6 times (3 years)
HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer
次要结局
- alpha-fetal protein(01/01/2014-31/12/2016, total 4 times (3 years))
- B ultrasound or MRI examination of the liver(01/01/2014-31/12/2016, total 2 times (3 years))
- Coagulation tests(01/01/2014-31/12/2016, total 6 times (3 years))
- Liver biopsy(01/01/2014-31/12/2016, total 2 times (3 years))
- liver function(01/01/2014-31/12/2016, total 6 times (3 years))
研究者
Yuehua Huang
director of liver disease laboratory
Third Affiliated Hospital, Sun Yat-Sen University