Evaluate the Efficacy And Safety Of TUDCA Compare UDCA In The Treatment Of Cholestatic Liver Disease-PBC by A Randomized,Double-Blind,Double Dummy,Parallel-Controlled,Multicenter Trial and The Consecutive Treatment By TUDCA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks.
研究概览
简要总结
Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.The more hydrophillic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA,and has been approved by state food and drug administration in China for treatment of cholesterol stones.So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double -dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome;decline of ALP,total bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.
详细描述
This is a double-blind, randomized, parallel controlled, multicenter, clinical trial. Subjects inclusion by randomization after passing the screening, continuous administration the test drug (Taurolite) or control drug (Ursofalk) treatment for 24 weeks. Compare the safety and efficacy of Taurolite vs Ursofalk.
At the end of the double-blind period，enroll 100 subjects from both two group randomly ,for a consecutive treatment use TUDCA up to 24 weeks. Further evaluate the efficacy and safety of tauroursodeoxycholic acid (TUDCA) in the treatment of adult primary biliary cirrhosis (PBC) for a long time up to one year. Also evaluate the regimen's efficacy and safety that udca take placed by TUDCA in the treatment of adult primary biliary cirrhosis (PBC) for the patients who use udca treatment for 24 weeks.
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
- Double (Participant, 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 Ages Eligible for Study: 18 Years to 70 Years
- •2 Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN);
- •3 Anti mitochondrial antibody (AMA) positive and / or anti-mitochondrial antibody subtype M2 (AMA-M2) positive; if the AMA and AMA-M2 were negative, need liver biopsy confirmed pathological changes in PBC.
排除标准
- •1．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy;
- •2．with extrahepatic biliary obstruction;
- •3．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection;
- •4．laboratory screening examination :
- •hemoglobin (HB): male< 11 g/dL, female <10 g/dL < g/dL;
- •the total white blood cell (WBC) count < 3000/mm3;
- •the absolute neutrophil count (ANC) <1500/mm3;
- •platelet (PLT) count <50000/mm3;
- •serum albumin <3.3g/dL;
- •alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;
- •ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;
- •total bilirubin (T-Bil) ≥ 4 ULN;
- •prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;
- •the serum creatinine (Cr) ≥ 1.5ULN.
- •5．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation;
- •6．diagnosed with liver cancer, suspected to have liver cancer, AFP > 100ng/ml. As the AFP in 2 times the upper limit of normal to 100ng/ml, need re-check in 2 weeks, if their AFP > 100ng/ml can not be included
- •7．body mass index >28 (Kg/m2);
- •8．alcohol or drug abusers within the recent year;
- •9．there is a serious heart, lung, kidney, digestive, nervous, mental disease, autoimmune diseases or malignant tumor
- •10．drug-induced liver injury;
- •plan to transplant or have had organ transplants;
- •12． are unable or unwilling to provide informed consent or fails to comply with the test requirements;
- •13．pregnant, lactating women.
研究组 & 干预措施
tauroursodeoxycholic
tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
干预措施: tauroursodeoxycholic (Drug)
ursodeoxycholic
control arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
干预措施: ursodeoxycholic acid (Drug)
结局指标
主要结局
Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks.
时间窗: 48 weeks
After 24 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 25% compared to the baseline. After 48 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 40% compared to the baseline.
次要结局
- The change of laboratory parameters about liver function(48 weeks)