EUCTR2018-001698-25-IT进行中（未招募）1 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 (CONSORCIO INSTITUTO DE INVESTIGACIONES BIOMèDICAS AUGUST PI I SUNYER)0 个研究点目标入组 240 人开始时间: 2020年10月7日最近更新:
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
- 入组人数
- 240
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, 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
- •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 normal at study inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Patients on treatment with statins or rifaximin up to one month
- •before study inclusion.
- •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
- •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.
- •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
- •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
- •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
- •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
研究者
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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.NL-OMON55488IDIBAPS (Institut d'Investigacions Biomediques August Pi i Sunyer)28