EUCTR2016-004499-23-ES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.
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:
- •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
相似试验
进行中（未招募）
1 期
Simvastatin plus rifaximin in decompensated cirrhosisEUCTR2016-004499-23-NLIDIBAPS45
进行中（未招募）
1 期
Simvastatin plus rifaximin in decompensated cirrhosisEUCTR2016-004499-23-FRIDIBAPS44
进行中（未招募）
1 期
Simvastatin plus rifaximin in decompensated cirrhosisPatients with decompensated cirrhosisMedDRA version: 20.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2016-004499-23-GBIDIBAPS45
招募中
2 期
Evaluating the safety and efficiency of the combined use of mask and hair spray with the iDR brand in repairing and improving the appearance of damaged hairhair damage.Hair color and hair shaft abnormalitiesIRCT20210130050179N8Vera Rahesh Pharmed Pharmaceutical Company14
进行中（未招募）
不适用
SEVICONTROL-1:Efficacy and safety of a fixed combination of olmesartan 40 mg/amlodipin 10 mg in patients with moderate essential hypertension not sufficiently controlled under monotherapy with candesartan 32 mg - an open phase IIIb trialEUCTR2011-004235-31-DEIPPMed GmbH