EUCTR2014-003107-29-IT进行中（未招募）1 期
A Phase IIb, double blind, randomized controlled clinical trial to evaluatethe efficacy and safety of two Aramchol doses versus placebo in patientswith Non-Alcoholic- Steatohepatitis (NASH). - ARREST
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
- 性别
- All
入选标准
- •1. Male or female age 18 to 75 years.
- •2. 25 = BMI =40 kg/m2 or waist circumference > 88 <200 cm for women and > 102 <200 cm for men.
- •3. Known type II Diabetes Mellitus or pre-Diabetes according to American Diabetes Association (one of three needed): Fasting Plasma Glucose > 100mg/dl (5.5 mmole/l) or 2hPG following 75g OGTT > 140
- •(7.8 mmole/l) mg/dl or HbA1C > 5.7%.
- •4. Histologically proven Steatohepatitis on a diagnostic liver biopsy performed within 6 months before randomization, confirmed by central laboratory reading of the slides (steatosis > 5%+ lobular inflammation, any ballooning, any amount).
- •5. Fat concentration in the liver of 5.5% or more as measured by NMRS.
- •6. Biopsies with an activity NAS score of 4 or more.
- •7. Normal synthetic liver function (serum albumin >3.5g/l, INR 0.8-1.3).
- •8. Signature of the written informed consent.
- •9. Negative pregnancy test at study entry for females of child bearing potential.
- •10. Females of child bearing potential practicing reliable contraception throughout the study period (including oral contraceptives).
- •11. Hypertensive patients must be well controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).
- •12. Patients previously treated with vitamin E (>400IU/day), Polyunsaturated fatty acid (>2g/day) or Ursodeoxycholic acid or fish oil can be included if drugs are stopped at least 3 months prior to diagnostic liver biopsy and up to the end of study.
- •13. For patients with type II Diabetes, glycaemia must be controlled (Glycosylated Hemoglobin A1C = 9% while any HbA1C increment should not exceed 1% during 6 month prior to enrollment). Treatments with Metformin, Sulfamides and Insulin are authorized. Sulfamides and insulin are permitted if glycaemia is self-monitored by the patient.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Patients with other active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, genetic hemochromatosis, Wilson disease,
- •alpha 1antitripsin deficiency, alcohol liver disease, drug induces liver disease) at the time of randomization.
- •2. Patients who have liver cirrhosis.
- •3. Known Alcohol and/or any other drug abuse or dependence in the last five years.
- •4. Known history or presence of clinically significant cardiovascular, hepatic other than NASH, gastrointestinal, metabolic other than Diabetes
- •Mellitus, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephrotic syndrome.
- •5. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolism (e.g. inflammatory bowel disease (IDB);
- •previous intestinal (ileal or colonic) operation; chronic pancreatic; celiac disease or previous vagotomy.
- •6. Patients with heart or brain pacemaker.
- •7. History of surgery during the last three month before screening which involved stent transplant or any other surgery which includes transplantation of metal devices (e.g. knee, hip etc.).
- •8. Weight loss of more than 5% within 6 months prior to randomization.
- •9. History of bariatric surgery in the past 5 years to liver biopsy.
- •10. Uncontrolled blood pressure.
- •11. Diabetes Mellitus other than type II (type I, endocrinopathy genetic syndromes etc.).
- •12. Patients with HIV infection.
- •13. Daily alcohol intake >20 g/day for women and 30 g/day for men.
- •14. Treatment with other anti-diabetic medications: DPP-4 inhibitors and GLP-1 receptor agonists (such as Genuvia, Sitagliptin, Byetta [Incretin], etc.).
- •15. Metformin, Fibrates, Statins, Insulin, sulfonylurea unless dose has een stabilized over the last 6 months.
- •16. Patients who are treated with Valproic acid, Tamoxifen, Methotraxete, Amiodaron.
- •17. Chronic antibiotic treatment (e.g. Rifaximin).
- •18. Homeopathic and/or Alternative treatments. Any treatment should be stopped before the screening period.
- •19. Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone >2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
- •20. Patients with renal dysfunction eGFR< 40.
- •21. Unexplained serum creatine phosphokinase (CPK) >3X the upper limit of normal (ULN). Patients with an intermittent CPK elevation may
- •have the repeated measurement prior to randomization; a CPK retest > 3X ULN leads to exclusion.
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