EUCTR2016-004499-23-GB进行中（未招募）1 期
Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial. - LIVERHOPE - simvastatin & rifaximin safety in decompensated cirrohosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- IDIBAPS
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years old.
- •2. Cirrhosis defined by standard clinical criteria and ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included. Patients with cirrhosis of autoimmune etiology on treatment with corticosteroids must be on stable corticosteroid dose for =3-month period before study inclusion.
- •3. Child Pugh B/C patients (from 7 to 12 points).
- •4. Women of child-bearing potential must have a negative pregnancy test in urine before the inclusion of the study and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / intrauterine hormone-releasing system) during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Patients on treatment with statins or rifaximin one month before study inclusion.
- •2. Patients on the waiting list for liver transplantation.
- •3. Patients with acute-on-chronic liver failure according to the criteria published by Moreau et al. (see appendix 1)
- •4. Serum creatinine =2 mg/dL.
- •5. Serum bilirubin>5 mg/dL.
- •6. INR =2.5.
- •7. Patients with CK elevation of 50% or more above the upper limit of normal at study inclusion.
- •8. Bacterial infection within 15 days before study inclusion.
- •9. Gastrointestinal bleeding within 15 days before study inclusion.
- •10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy.
- •11. HIV infection.
- •12. Hepatocellular carcinoma outside Milan criteria, defined as a single nodule =5 cm or a maximum of 3 nodules with none >3 cm.
- •13. Patients on antiviral therapy for HCV or those who have received it within the last 6 months.
- •14. Patients with previous history of myopathy.
- •15. Patients on treatment with potent inhibitors of CYP3A4 enzyme (See section 5.2: Concomitant, nonpermitted and permitted medication)
- •16. Patients on treatment with drugs with potential interactions with simvastatin (see section 5.2: Concomitant, nonpermitted and permitted medication)
- •17. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- •18. Patients with current extrahepatic malignancies including solid tumours and hematologic disorders.
- •19. Patients with previous history or increased risk of intestinal obstruction.
- •20. Pregnancy or breastfeeding.
- •21. Patients included in other clinical trials in the previous month.
- •22. Patients with active alcohol consumption of more than 3 units per day.
- •23. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- •24. Severe alcoholic hepatitis requiring corticosteroid therapy (Maddrey’s Discriminant function = 32 and/or ABIC score > 6.7).
- •25. Refusal to give informed consent.
- •26. Patients with contraindications for statins or rifaximin.
- •27. Known hypersensitivity to rifaxamin (or rifamycin derivatives) or to simvastatin.
研究者
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