EUCTR2016-004148-13-PT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this
- •1) Willing and able to give informed consent prior to any study specific procedures being performed.
- •2) Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis, hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score [NAS]) and cirrhosis (F4 fibrosis) according to the NASH CRN classification, in the opinion of the central reader.
- •3) Subject has the laboratory parameters at the Screening visit, as determined by the central laboratory.
- •4) Body Mass Index (BMI) = 18 kg/m2 at Screening.
- •5) Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit.
- •6) Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
- •7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
- •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 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1) Prior history of decompensated liver disease, including clinical ascites, HE, or variceal bleeding
- •2) CP score > 7, as determined at Screening, unless due to therapeutic
- •anti-coagulation.
- •3) MELD score > 12, as determined at Screening, unless due to therapeutic
- •anti-coagulation.
- •4) Chronic HBV infection (HBsAg positive).
- •5) Chronic HCV infection (HCV Ab and HCV RNA positive). Subjects cured of HCV infection less than 5 years prior to the Screening visit are not eligible.
- •6) Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/or centralized review of liver histology.
- •7) History of liver transplantation.
- •8) Current or history of HCC.
- •9) Any weight reduction surgery in the 2 years prior to Screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (e.g., Roux-en-Y or distal gastric bypass) at any time prior to Screening.
- •10) Weight loss > 10% within 6 months of Screening.
- •11) HIV infection (HIV Ab and HIV ribonucleic acid [HIV RNA] positive).
- •12) Current alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1oz/30mL of alcohol is present in 1 12oz/360mL beer, 1 4oz/120mL glass of wine, and a 1 oz/30 mL measure of 40 proof alcohol).
- •13) Positive urine drug screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at
- •Screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator.
- •14) Unstable cardiovascular disease.
- •15) Use of any prohibited concomitant medication as described in Section 5.4. Subjects on Vitamin E must be on a stable dose for at least 6 months prior to the diagnostic liver biopsy and subjects on antidiabetic medications must be on a stable dose for at least 3 months prior to diagnostic liver biopsy.
- •16) History of a malignancy within 5 years of Screening.
- •17) Unable to safely undergo a liver biopsy.
- •18) Participation in another investigational study of a drug or device within 30 days or within 5 half-lives of the prior investigational agent (whichever is longer) prior to Screening.
- •19) Concurrent participation in another therapeutic clinical study.
- •20) Known hypersensitivity to SEL, the metabolites, or formulation excipient.
- •21) Any laboratory abnormality or condition that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- •22) Presence of any condition th
研究者
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