NCT01141296撤回2 期
Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Serum alkaline phosphatase level
研究概览
简要总结
The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 and ≤ 75 years old
- •Established diagnosis of PBC and positive AMA
- •Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
- •Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
- •Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
- •Signed informed consent after careful review of information and study details
排除标准
- •Hypersensitivity to fenofibrate
- •Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
- •Prisoners and institutionalized subjects, pregnant or nursing women
- •Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score).
- •Recipients of liver transplantation
- •Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- •Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
- •Acute or chronic renal failure, defined as GFR < 60 ml/min
- •Known history of cholecystitis with intact gallbladder
- •History of, or known high risk for, venous thromboembolism
- •Current use of warfarin or statins
研究组 & 干预措施
Fenofibrate
Active Comparator
干预措施: fenofibrate (Drug)
sugar pill
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Serum alkaline phosphatase level
时间窗: one year
次要结局
- Symptoms - quality of life(one year)
- symptoms - pruritus(one year)
- symptom -fatigue(one year)
- interleukin 1(one year)
- interleukin 6(one year)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
2 期
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CholangitisPrimary Biliary CholangitisNCT06174402Han Ying184
招募中
2 期
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary CholangitisPrimary Biliary CholangitisNCT05749822Xijing Hospital of Digestive Diseases104
已完成
2 期
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 DiabetesPatients With Type 2 DiabetesNCT00703482Solvay Pharmaceuticals278
已完成
不适用
Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer PatientsBreast Cancer Stage 2 and 3NCT06155331Tanta University44
已完成
3 期
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of PregnancyPregnancyIntrahepatic CholestasisNCT01576458Turku University Hospital20