EUCTR2015-004473-32-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •1. Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- •2. Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
- •Diagnosis of cirrhosis is based on:
- •- Biopsy OR
- •- Clinical evidence: platelet count < 150,000, AST > ALT, and either nodular liver surface on imaging or splenomegaly
- •NASH is based on 1 of the following:
- •- Prior or current biopsy showing steatohepatitis (fat, ballooning degeneration, inflammation) consistent with NASH
- •- At least 2 metabolic risk factors for at least 5 years preceding the diagnosis of cirrhosis: diabetes mellitus, impaired fasting glucose, obesity (BMI = 30 kg/m2 or central obesity), hypertension, dyslipidemia (see Appendix IV)
- •- Prior or current biopsy showing some but not all diagnostic features of NASH (e.g. only fat or ballooning degeneration or inflammation) but with no evidence for viral hepatitis or other liver disease AND either fatty liver disease on prior imaging or at least 1 metabolic risk factor (as above) for at least 5 years preceding the diagnosis of cirrhosis
- •3. Compensated cirrhosis (no history of or presence of clinically evident ascites, variceal hemorrhage, or encephalopathy, and on no medications to treat these complications)
- •Decompensated cirrhosis with no more than 1 prior significant decompensating event:
- •a. If prior decompensating event was variceal hemorrhage, event must have occurred at least 3 months prior to Day 1
- •b. If prior decompensating event was ascites requiring chronic diuretics, ascites should be well controlled (not clinically evident, i.e. no ascites or ascites only detectable by ultrasound examination) on a stable dose of diuretics for at least 3 months prior to Day 1
- •c. If prior decompensating event was hepatic encephalopathy = grade II or requiring hospitalization, encephalopathy should be well-controlled (Stage 0 or 1) on stable medication for at least 3 months prior to Day 1
- •Note: Previous transient ascites or hepatic encephalopathy in a subject who is currently stable without clinically evident ascites or encephalopathy and on no medications for these conditions does not count as a prior significant decompensating event
- •4. Severe portal hypertension defined as HVPG =12 mmHg (see Section 8.4.1 for recommendations to identify subjects more likely to meet the HVPG criteria)
- •5. Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
- •6. Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
- •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 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1. Evidence of severe decompensation, defined as:
- •a. Presence or history of more than one type of significant decompensating event (clinically evident ascites requiring chronic diuretics, variceal hemorrhage, and/or overt encephalopathy)
- •Note: Previous transient ascites or hepatic encephalopathy in a subject who is currently stable without clinically evident ascites or encephalopathy and on no medications for these conditions does not count towards this exclusion (see Inclusion Criteria #4).
- •b. One type of decompensating event with the following characteristics:
- •- More than 1 episode of variceal hemorrhage or bleeding from a portal hypertensive source (e.g. portal hypertensive gastropathy)
- •- Ascites that has required more than 1 large-volume paracentesis (>5 L) for treatment or that has been complicated by spontaneous bacterial peritonitis, hyponatremia (serum Na <130), and/or hepatorenal syndrome
- •- More than 1 episode of overt hepatic encephalopathy requiring hospitalization
- •2. Severe hepatic impairment defined as a Child-Pugh score =10
- •3. ALT or AST >5 times upper limit of normal (ULN) during screening
- •4. Estimated creatinine clearance <30 mL/min
- •5. Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
- •6. Known portal vein thrombosis
- •7. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
- •8. Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications
- •9. Alpha-fetoprotein >200 ng/mL
- •10. History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of >500 msec
- •11. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
- •12. Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening
- •13. Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject’s ability to comply with study procedures and study drug administration in the investigator’s judgement
- •14. If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
- •15. Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1
研究者
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