NCT03082885已完成不适用
A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The liver transplantation-free survival rate of 90 days
研究概览
简要总结
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
详细描述
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, the investigators intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
- •2.Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
- •3.Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
- •4.Development of coagulopathy(PTA≤40% or INR≥1.5 ).
- •More than one of the 5-8 criteria：
- •5.Development of hepatic encephalopathy.
- •6.Development of hepatorenal syndrome.
- •7.Hepatic narrowing progressively.
- •8.Development of massive ascites or peritonitis.
- •Willing to provide informed consent and comply with the test requirements
排除标准
- •1.Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
- •2.Patients who have autoimmune disease (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, etc ) or with abnormal elevation level of autoimmune antibody.
- •3.Model for end-stage liver disease (MELD) score <17 or >
- •4.Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
- •5.Patients with diseases that researchers consider inappropriate to participate in the study.
- •6.Patients who have disseminated intravascular coagulation.
- •7.Drug allergy.
- •8.Patients with any other contraindications to thymosin alpha
- •9.Patients who participated in other clinical trials at the same time.
研究组 & 干预措施
Thymosin-α1 group
Experimental
Patients receive treatment based on standard Therapy with additional Thymosin-α1
干预措施: Thymosin-α1 (Drug)
结局指标
主要结局
The liver transplantation-free survival rate of 90 days
时间窗: 90 days
Survival condition of the patients were observed for 90 days
次要结局
- Hepatitis B virus DNA load change(24 weeks)
- Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia(24 weeks)
- Complications after 48 hours admission(24 weeks)
- The liver transplantation-free survival rate of 180 days(180 days)
- Causes of death/liver transplantation(24 weeks)
- Inflammatory indexes change(24 weeks)
- Alanine aminotransferase change(24 weeks)
- Glutamic oxaloacetic transaminase change(24 weeks)
- Total bilirubin change(24 weeks)
- Plasma thrombin time change(24 weeks)
- Albumin time change(24 weeks)
研究者
Lin Bingliang
professor
Sun Yat-sen University
研究点 (1)
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