EUCTR2019-002073-56-FR进行中（未招募）1 期
A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH) The ARMOR Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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 age 18 to 75 years (inclusive at first Screening visit)
- •2. Histological confirmation of NASH on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period)
- •3. Total NAS Score 4 or more with at least 1 in each component of the NAS Score (steatosis =1 AND inflammation =1 AND ballooning =1)
- •4. Fibrosis Stage must be 2 or 3
- •5. Subjects who have had a biopsy more than 3 months before
- •randomization should have stable weights between the time of the
- •biopsy and screening. Stable weight is defined as no more than a 5
- •percent change
- •6. Body mass index (BMI) between 25kg/m2 and 40 kg/m2
- •7. AST>20 IU/L
- •8. Type 2 diabetes mellitus or prediabetes: Type 2 diabetes diagnosis must be established and documented prior to screening. For prediabetes, the diagnosis should be based on screening results (by central lab) according to the American Diabetes Association criteria, which requires at least one of the following 3 criteria:
- •Fasting Plasma Glucose > 100mg/dL (5.5 mmol/L)
- •Post-load glucose (2hPG) following 75g oral glucose tolerance test (OGTT) > 140 mg/dL (7.8 mmol/L)
- •Glycosylated Hemoglobin (HbA1c) > 5.7%
- •9. For subjects with type 2 diabetes, glycemia must be controlled (HbA1c = 9%)
- •10. Negative blood pregnancy test at study entry for females of childbearing potential confirmed by central laboratory
- •11. Females of childbearing potential must practice a highly effective
- •method of contraception throughout the study period and for 1 month after treatment discontinuation. Highly effective methods are defined as those that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods, in accordance with the recommendations of the Clinical Trial Facilitation Group (CTFG) Working Group on Contraception include: Hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence
- •12. Able to understand the nature of the study and to provide signature of the written informed consent
- •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 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •1. Histologically documented liver cirrhosis (fibrosis stage 4)
- •2. Inability or unwillingness to undergo a liver biopsy
- •3. Abnormal synthetic liver function
- •Albumin below the lower limit of the normal range
- •International Normalized Ratio (INR) = 1.3; unless related to use of
- •anticoagulants
- •Total bilirubin = 1.3 mg/dL (22.2 µmol/L); patients with a documented history of Gilbert’s syndrome can be enrolled if the direct bilirubin is within normal reference range
- •4. ALT or AST >5× upper limit of normal (ULN); according to central
- •5. Platelet count < 150,000mm3
- •6. Alkaline phosphatase =2× ULN
- •7. Known or suspected hepatocellular carcinoma (HCC)
- •8. Model for End-Stage Liver Disease (MELD) score > 12 unless related to anticoagulant use
- •9. Prior history of/or planned liver transplantation
- •10. Prior history or presence of decompensated liver disease
- •11. Evidence of portal hypertension (e.g., low platelet counts, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly)
- •12. Other (acute or chronic) coexisting liver disease based on medical history and/or centralized review of liver histology (e.g. viral hepatitis, unless eradicated at least 3 years prior to screening; Primary biliary cholangitis (PBC); Primary sclerosing cholangitis (PSC); genetic hemochromatosis; Wilson disease; alpha 1 antitrypsin deficiency; autoimmune hepatitis; alcoholic liver disease; drug-induced liver disease)
- •13. Known alcohol and/or any other drug abuse or dependence in the last five years
- •Daily alcohol intake will be an exclusion if >20 g/day for women and
- •>30 g/day for men (on average per day), as per medical history
- •14. Human immunodeficiency virus HIV infection (either known or diagnosed during Screening blood tests)
- •15. Known familial (i.e., genetic) hypertriglyceridemia and familial (i.e., genetic) hypercholesterolemia
- •16. Diabetes Mellitus other than type 2 (type 1, endocrinopathy, genetic syndromes etc.)
- •17. Weight loss of more than 5% within 3 months prior to screening
- •18. History of bariatric surgery within 5 years of liver biopsy or planned surgery for weight reduction
- •19. Treatment with drugs that may cause NAFLD within 12 months prior to liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, chronic treatment with corticosteroids, high dose estrogen and tetracycline)
- •20. Treatment with Vitamin E unless started at least 12 months prior to biopsy, with stable dose in the 6 months prior to biopsy
- •Subjects that stopped treatment less than 6 months prior to biopsy
- •should be excluded
- •21. Treatment with GLP-1 receptor agonists or thiazolidinediones (TZDs) unless started at least 12 months prior to biopsy, with stable dose in the 6 months prior to biopsy
- •Subjects that stopped treatment less than 6 months prior to biopsy
- •should be excluded
- •22. Treatment with SGLT-2 inhibitors, metformin, sulfonylurea, insulin, and DPP-4 inhibitors unless the prescribed dose
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