EUCTR2015-005385-38-NL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genfit SA
- 入组人数
- 2,224
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. Males or females aged from 18 to 75 years inclusive at first Screening Visit.
- •2. Must provide signed written informed consent and agree to comply with the study protocol.
- •3. Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as
- •described below:
- •o Cessation of menses for at least 12 months due to ovarian failure,
- •o Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
- •o If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
- •o Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
- •o Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
- •4. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to Screening or during the Screening Period) with at
- •least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
- •5. NAS =4.
- •6. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system. For patients with fibrosis stage 1, only patients at high risk of progression will be included meaning with a NAS =5 and at least 2 of the following conditions: persistent elevated ALT (absence of normal value of ALT within the past year), obesity defined by a BMI =30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
- •7. Patients in whom it is safe and practical to proceed with a liver biopsy, and who agree to have:
- •o 1 liver biopsy during the Screening Period for diagnostic purpose (if no historical biopsy within 6 months before Screening is available)
- •o 1 liver biopsy after 72-weeks of treatment for assessment of the treatment effects on NASH
- •o a final liver biopsy after approximately 4 years of treatment (V13), unless a liver biopsy has already been performed within the past year
- •o 1 liver biopsy performed only in the case of suspicion of cirrhosis (to have a histological confirmation).
- •8. If a patient is treated with 1 of the following drugs: vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or ursodeoxycholic acid; a stable dose from at least 6 months prior to diagnostic liver biopsy is required.
- •9. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
- •o no qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for patients treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitor
排除标准
- •1. Known chronic heart failure (Grade I to IV of New York Heart Association classification).
- •2. History of efficient bariatric surgery within 5 years prior to Screening, or planned bariatric surgery in the course of the study.
- •3. Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy.
- •4. Type 1 diabetes patients.
- •5. Patients with hemoglobin A1c [HbA1c] >9.0%. If abnormal at the first Screening Visit, the HbA1c measurement can be repeated at the latest 2 weeks prior to Randomization. A repeated abnormal HbA1c (HbA1c >9.0%) leads to exclusion.
- •6. Patients receiving thiazoledinediones (glitazones [pioglitazone, rosiglitazone]) unless the drug was discontinued at least 6 months before the diagnostic liver biopsy.
- •7. Patients with a history of clinically significant acute cardiac event within 6 months prior to Screening such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- •8. Weight loss of more than 5% within 6 months prior to Randomization.
- •9. Compensated and decompensated cirrhosis (clinical and/or histological evidence of cirrhosis). Notably, NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system
- •are excluded.
- •10. Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is typically defined as higher than 30 g pure alcohol per day. For women, it is typically defined as higher than 20 g pure alcohol per day.
- •11. Pregnant or lactating females or females planning to become pregnant during the study period.
- •12. Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
- •o positive hepatitis B surface antigen
- •o positive hepatitis C Virus (HCV) RNA (tested for in case of known cured HCV infection or positive HCV Ab at Screening)
- •o suspicion of drug-induced liver disease
- •o alcoholic liver disease
- •o autoimmune hepatitis
- •o Wilson’s disease
- •o primary biliary cirrhosis, primary sclerosing cholangitis
- •o genetic homozygous hemochromatosis
- •o known or suspected hepatocellular carcinoma (HCC)
- •o history or planned liver transplant, or current MELD score >12
- •13. Where applicable, patients not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force applicable to clinical trials.
- •14. Patients who cannot be contacted in case of emergency.
- •15. Known hypersensitivity to the investigation product or any of its formulation excipients.
- •16. Patients with previous exposure to elafibranor.
- •17. Patients who are currently participating in, plan to participate in, or have participated in an investigational drug trial or medical device trial containing active substance within 30 days or five half-lives, whichever is longer, prior to Screening.
- •Concomitant medications:
- •18. Fibrates are not permitted from 2 months before Randomization. Patients that used statins, ezetimibe, or other nonfibrate lipid lowering drugs before Screening may participate if the dosage has been kept constant for at least 2 months prior to Screening.
- •19. Currently taking drugs that can induce steatosis/steatohepatitis including, but not restricted to: corticosteroids (parenteral & oral chronic administration only), amiodarone (Cordarone), tamoxifen (Nolvadex), and methotrexate (Rheumatrex, Trexall), which are not permitted 30 days prior
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