EUCTR2020-004986-38-PL进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, multicentre, Phase 3 studyevaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis - NATIV3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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. Able to understand the nature of the study, willing and able to comply with the study procedures and restrictions, and ableto provide signed, dated and written informed consent obtained before any study-related activities, sampling or analysis.
- •2. The patient will be willing to continue on the study in case of moving or relocation during the first 72 weeks of the study.
- •3. Male or female, aged =18 years at the time of signing informed consent
- •4. If biopsy performed before Screening, i.e. if a historical biopsy is available, a histological diagnosis of NASH with liver fibrosis must be made no more than 7 months before randomization
- •5. Main cohort: Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
- •a.Steatosis score =1
- •b.Activity score: A3 or A4
- •c.Fibrosis score: F2 or F3
- •Exploratory cohort: Patients who, upon central biopsy reading process, do not meet the eligibility criteria described above but fulfil the following criteria: diagnosis of NASH according to the Steatosis-Activity- Fibrosis (SAF):
- •a) Steatosis score =1
- •b) Activity score =2 with SAF-Inflammation score =1 and SAF-Ballooning score =1
- •c) Fibrosis score: any stage (F1 to F4)
- •6. Model for End-Stage Liver Disease (MELD) score =12(unless patient is on anticoagulants)
- •7.For patients receiving the concomitant medications listed below: no qualitative change in dose are allowed (changes having minimal clinical impact like temporary cessation/change between class of drugs are allowed), for the specified period prior to the qualifying liver biopsy and dose must remain stable from the time of the liver biopsy until the Baseline visit (Visit 0) :
- •a.Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists including combinations) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): Stable dose for at least 3 months
- •b.Vitamin E (if at a dose =400 IU/day): Stable dose for at least 6 months
- •c.Statins: Stable dose for at least 3 months
- •d. Anti-obesity treatments for at least 6 months
- •8.For patients receiving concomitant medications not covered by criterion #7 and that may impact safety or efficacy evaluation (including but not limited to antidiabetic treatments other than GLP1(or combinations) receptor agonists and SGLT2 inhibitors, antihypertensives, antidepressants, cardiovascular, antihyperlipidemic, etc) no qualitative change in dose are allowed for at least 3 months prior to the Screening visit until Baseline visit (Visit 0).
- •9. For overweight/obese patient, history of at least 1 unsuccessful attempt to reduce body weight by diet and/or exercise within the past 6 years up to 6 months prior to Screening
- •10. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
- •11. Criterion removed in Version 3.0 on
- •12. Patient agrees to follow recommendations with lifestyle modifications, which will be monitored throughout the whole study period.
- •13. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory.. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation. Highly effective contraceptive methods are defined as follows: combined (oestrogen and progestogen containing) hormonal contraception as
排除标准
- •Liver-related:1. Documented causes of chronic liver dise. other than NASH including, but not restricted to:a.Viral hepatitis, documented with,i.Positive hepatitis B surface antigen (HBsAg),ii.Positive hepatitis C virus ribonucleic acid (RNA) (tested for in case of known cured hepatitis C virus [HCV] infection or positive HCV serology at Screening). Patients with a history of HCV infection can be included if HCV PCR is negative since more than 3 years.
- •b.Drug-induced liver disease,c.Alcoholic liver disease,d.Autoimmune hepatitis,e.Wilson’s disease,f.Haemochromatosis,g.Primary biliary cholangitis ,h.Primary sclerosing cholangitis,i.Alpha-1-antitrypsin deficiency,j)Chronic portal vein thrombosis or splenic vein thrombosis
- •2. Histo. documented liver cirrhosis in the most recent historical biopsy (fibrosis stage F4), either at Screening or in a his.biopsy or suspicion at screening of cirrhosis based on clinic biochemical and imaging criteria upon investigator's assessment (see Section 9.1.1)
- •3. History or current diagnosis of HCC
- •4. History of or planned liver transplant
- •5. Inability or unwillingness to undergo a liver biopsy at Screening (if a suitable hist.biopsy is unavailable for central review), at Week 72, and after the non-invasive algorithm suggests high risk of progression to F4 OR at the End of Study)
- •6. Positive human immunodeficiency virus (HIV) serology
- •7. ALT or AST >5 × ULN
- •7.1. AST < 0.60 × ULN if the screening liver biopsy has to be performed in the scope of the study
- •7.2. Liver Stiffness Measurement (LSM) < 6 kPa by transient elastography (or equivalent) during screening if the screening liver biopsy has to be performed in the scope of the study.
- •8. Abnormal synthetic liver function as defined by Screening central lab.evaluation of any of the following:
- •a.Albumin below the lower limit of the normal range
- •b.International normalised ratio (INR) =1.3 (unless patient is on anticoagulants)
- •c.Total bilirubin level =1.5 mg/dL (22.2 µmol/L).Patients with a documented history of Gilbert’s syndrome can be enrolled if the direct bilirubin is =0.45 mg/dL (7.7 µmol/L.
- •9. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males
- •10. Leucocytes count < LLN.A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
- •11. Platelet count <140,000/µL
- •12. Alkaline phosphatase (ALP) >2 × ULN
- •13. Patient currently receiving any app.treatment for NASH or obesity
- •14. Current or recent history (<5 years) of significant alcohol consumption, which is typically defined as higher than 30 g pure alcohol per day for men and as higher than 20 g pure alcohol per day for women (please also refer to Section 13.1). No binge drinking during the last
- •year. Consuming 75 g pure alcohol (male), or 60 g pure alcohol (female), or more in about 2 hours
- •15. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids >5 mg/day of prednisone equivalent [one short (<2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed], or oestrogens [at doses greater than those used for contraception or hormone replacement])
- •Glycaemia related:16. HbA1c >9% at Screening
- •17. Diabetes mellitus other than type 2 (e.g. type 1, endocrinopathy, and genetic synd
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