EUCTR2020-006023-33-ES进行中（未招募）1 期
Efficacy of simvastatin reducing liver fibrosis in patients with advanced fibrosis due to alcohol: a randomized, double-blind, placebo-controlled clinical trial. - SIMFIB
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •2. Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) (ishak 3-6)and with data of significant liver fibrosis obtained in the diagnostic biopsy at the beginning of the study or in the last biopsy of the patient within 6 months prior to randomization. Significant liver fibrosis is defined by a score on the Ishak fibrosis scale of between 3 and 6.
- •3. Patients in the compensated chronic liver disease phase defined by the absence of clinical decompensations at the time of entering the study, with or without data of portal hypertension.
- •4. Women of childbearing potential must have a negative urine pregnancy test prior to study enrollment and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / hormone delivery system intrauterine) during the study.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Patients receiving statins or fibrates.
- •2. Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
- •3. Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
- •4. Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
- •5. Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
- •6. Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
- •7. Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
- •8. Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
- •9.Child-Pugh > 8
- •10. Hepatocellular carcinoma of any stage.
- •11. Patients with known muscle disease.
- •12. Patients with previous rhabdomyolysis.
- •13. Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
- •14. Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
- •15. Patients with a history of significant extrahepatic disease with poor short-term prognosis, including New York Heart Association Grade III / V congestive heart failure, GOLD COPD> 2, chronic kidney disease with serum creatinine> 2mg / dL or under therapy of kidney replacement.
- •16. Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
- •17. Patients with a history or increased risk of intestinal obstruction.
- •18. Pregnancy or breastfeeding.
- •19. Patients included in other clinical trials during the previous month.
- •20. Patients with mental disabilities, language barriers, poor social support or any other reason considered by the researcher as essential for adequate understanding, cooperation or compliance with the study.
- •21. Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
- •22. Patients with contraindications for statins.
- •23. Known hypersensitivity to simvastatin.
- •24. Refusal to sign the informed consent.
研究者
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