A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 25
- 主要终点
- The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
研究概览
简要总结
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic 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 AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA 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
- •written informed consent
- •aged 18-70 years
- •increase in alkaline phosphatase for 2 folds or more
- •positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed as PBC with histologic evidence.
排除标准
- •patients who had been treated with UDCA, immunosuppressive medications within 3 months.
- •patients who had evidence of extrahepatic biliary obstruction
- •patients coinfection with HBV or HCV
- •patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl in female 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4) platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN.
- •patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.)
- •definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP>100ng/ml.Patients with AFP>2×ULN while <100ng/ml should re-test 2 weeks later.
- •Body Mass Index >28 kg/m2
- •drug or alcohol abuse.
- •patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor
- •patient had or on the scheduled of organ transplantation;
- •patient for whom the follow-up is considered impossible
- •pregnant or nursing woman
研究组 & 干预措施
Group 1
Tauroursodeoxycholic Acid Capsules,250mg,tid.
干预措施: Tauroursodeoxycholic Acid Capsules (Drug)
Group 2
Ursodeoxycholate acid capsules, 250mg,tid,
干预措施: Ursodeoxycholic Acid Capsules (Drug)
结局指标
主要结局
The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
时间窗: 12 months
次要结局
- GGT decline from baseline after 24 weeks treatment of TUDCA(12 months)
- ALT and AST decline from baseline after 24 weeks treatment of TUDCA(12 months)
- ALP decline from baseline after 24 weeks treatment of TUDCA(12 month)
- Total bilirubin decline from baseline after 24 weeks treatment of TUDCA(12 months)
研究者
Jia Ji-Dong
Professor
Beijing Friendship Hospital