NCT04971577招募中2 期
Efficacy of Simvastatin in Reducing Liver Fibrosis in Patients With Advanced Fibrosis Due to Alcohol: Randomized, Double-blind, Placebo-controlled Clinical Trial
Anna Cruceta1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline biopsy in histological fibrosis Ishak score (0-4 range. higher scores mean a worse result)
研究概览
简要总结
Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Chronic alcohol-related liver disease according to international guidelines (EASL, European Association for the Study of the Liver) 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
- •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.
- •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.
排除标准
- •Patients receiving statins or fibrates.
- •Patients with other etiologies of liver disease in addition to alcohol: hepatitis C, hepatitis B, autoimmune hepatitis, Wilson's disease, or hemochromatosis.
- •Patients in whom hepatitis C has been cured with antivirals in the 2 years prior to inclusion in the study.
- •Patients with a CK elevation of 50% or more above the upper limit of normal at the time of study inclusion.
- •Gastrointestinal bleeding due to portal hypertension within 12 months prior to inclusion in the study.
- •Clinical hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy, in the 12 months prior to inclusion in the study.
- •Patients in need of diuretic treatment in the previous 12 months to control ascites or hydrothorax.
- •Spontaneous bacterial peritonitis within 12 months prior to study enrollment.
- •Hepatocellular carcinoma of any stage.
- •Patients with known muscle disease.
- •Patients with previous rhabdomyolysis.
- •Patients being treated with strong CYP3A4 enzyme inhibitors (see section 5.2: Concomitant drugs, not allowed and allowed).
- •Patients being treated with drugs with possible interactions with simvastatin (see section 5.2: Concomitant drugs, not allowed and allowed).
- •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.
- •Patients with extrahepatic malignancies, including solid tumors and hematologic malignancies.
- •Patients with a history or increased risk of intestinal obstruction.
- •Pregnancy or breastfeeding.
- •Patients included in other clinical trials during the previous month.
- •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.
- •Presence of data on alcoholic hepatitis in liver biopsy upon inclusion.
- •Patients with contraindications for statins.
- •Known hypersensitivity to simvastatin.
- •Refusal to sign the informed consent
研究组 & 干预措施
Control arm
Placebo Comparator
干预措施: Simvastatin 40mg (Drug)
Treatment arm
Experimental
干预措施: Simvastatin 40mg (Drug)
结局指标
主要结局
Change from baseline biopsy in histological fibrosis Ishak score (0-4 range. higher scores mean a worse result)
时间窗: 18 months
Change from range baseline biopsy in histological fibrosis score measured through the Ishak scale at 18 months.
次要结局
未报告次要终点
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica
研究点 (1)
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