NL-OMON55488已完成3 期
Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial. - LIVERHOPE_EFFICACY
IDIBAPS (Institut d'Investigacions Biomediques August Pi i Sunyer)0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients included into the study must meet all the following criteria:
- •1. Age >= 18 years old.
- •2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings
- •and/or histology. Cirrhosis of any aetiology may be included. However, patients
- •with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid
- •dose for >=3-month period before study inclusion.
- •3. Child-Pugh B patients or Child-Pugh C patients (up to 12 points).
- •4. Women of child-bearing potential must have a negative pregnancy test in
- •serum before the inclusion in the study and agree to use highly effective
- •contraceptive methods during the study. Highly effective contraceptive methods
- •will include: intrauterine device, bilateral tubal occlusion, vasectomized
- •partner and sexual abstinence. (only if refraining from heterosexual
- •intercourse during the period of twelve months of duration of the study and
- •extended to 30 days after the end of the study treatment) Hormonal
- •contraceptive methods will be avoided due to the risk of adverse events and
- •impairment of liver function.
排除标准
- •1. Patients on treatment with statins or rifaximin up to one month before study
- •2. Patients with contraindications for statins or rifaximin therapy.
- •3. Known hypersensitivity to simvastatin or rifaximin (or rifamycin
- •derivatives).
- •4. Patients with CK elevation of 50% or more above the upper limit of normal at
- •study inclusion.
- •5. Patients on treatment with potent inhibitors of CYP3A4 enzyme (see section
- •5.2: Concomitant, nonpermitted and permitted medication).
- •6. Patients on treatment with drugs with potential interactions with
- •simvastatin (see section 5.2: Concomitant, nonpermitted and permitted
- •medication).
- •7. Patients with previous history of myopathy.
- •8. Patients with previous history of intestinal obstruction or those who are at
- •increased risk of this complication.
- •9. Patients with ACLF according to the criteria published by Moreau et al. (see
- •appendix 2).
- •10. Serum creatinine >=2 mg/dL (176.8 µmol/L).
- •11. Serum bilirubin>5 mg/dL (85.5 µmol/L).
- •12. INR >=2.5. Patients under anticoagulant therapy will be excluded if the INR
- •values are >= 3.5
- •13. Bacterial infection within 10 days before study inclusion.
- •14. Gastrointestinal bleeding within 10 days before study inclusion.
- •15. Current overt hepatic encephalopathy, defined as grade II-IV hepatic
- •encephalopathy according to the New-Haven classification.
- •16. Patients with active hepatocellular carcinoma or history of hepatocellular
- •carcinoma that is in remission for less than six months for uninodular HCC or
- •for less than 12 months for multinodular HCC within Milan criteria.
- •17. Patients on antiviral therapy for HCV or those who have received it within
- •the last 6 months.
- •18. Severe alcoholic hepatitis requiring corticosteroid therapy (Maddrey*s
- •Discriminant function >= 32 and/or ABIC score > 6.7).
- •19. Patients with active alcohol consumption of more than 21 units per week.
- •20. HIV infection.
- •21. Patients with a history of significant extra hepatic 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.
- •22. Patients with current extra hepatic malignancies including solid tumours
- •and hematologic disorders.
- •23. Pregnancy or breastfeeding.
- •24. Patients included in other clinical trials in the month before inclusion.
- •25. 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.
- •26. Refusal to give informed consent.
- •27. Creatinine clearance < 30 ml/min
- •28. Patients with cirrhosis due to cholestatic liver disease can only be
- •included in the study if they present clinical decompensation of cirrhosis
- •(i.e. ascites).
- •29. Patients with previous organ transplantation.
研究者
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