EUCTR2020-004986-38-AT进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an activetreatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis - NATIV3
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 is 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 randomisation
- •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 cotransporter-
- •2 inhibitors (SGLT2 inhibitors): for at least 3 months
- •b. Vitamin E (if at a dose =400 IU/day): for at least 6 months
- •c. Statins 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 (antidiabetic treatments other than GLP1 (or combinations) receptor agonists and SGLT2 inhibitors, antihypertensives, antidepressants, cardiovascular, antihyperlipidemic) no qualitative change in dose are allowed for at least 3 months prior to the 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
- •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 from 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 associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of o
排除标准
- •Liver-related:
- •1. Documented causes of chronic liver disease other than NASH including, but not restricted to:
- •a. Viral hepatitis
- •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. Histologically documented liver cirrhosis in the most recent historical
- •biopsy (fibrosis stage F4) or suspicion at screening of cirrhosis based on
- •clinic biochemical and imaging criteria
- •3. History or current diagnosis of hepatocellular carcinoma (HCC)
- •4. History of or planned liver transplant
- •5. Inability or unwillingness to undergo a liver biopsy at Screening (if a suitable historical biopsy is unavailable for central review) and at Week 72
- •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 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 (25.6 µmol/L) Patients with a 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 approved treatment for NASH
- •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
- •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
- •Glycaemia related:
- •16. HbA1c >9% at Screening
- •17. Diabetes mellitus other than type 2
- •18. Current treatment with insulin
- •19.Treatment with PPAR-gamma agonists 12 months before randomisation, or any history of stopping TZD due to safety reason
- •Obesity related:
- •20. Bariatric surgery: Restrictive procedures (e.g. lap banding, intragastric balloon, sleeve gastrectomy) are allowed, if performed >6 months prior to the qualifying liver biopsy; malabsorptive procedures (e.g. biliopancreatic diversion) and procedures combining both restrictive and malabsorptive methods are not allowed within 5 years of the qualifying liver biopsy. Liposuction and/or abdominoplasty are allowed if performed >6 months before qualifying liver biopsy. Planned bariatric surgery is not allowed 21. New participation in an organised weight-loss programme within 6 months of the study, or planned participation through Week 72 or current treatment with orlistat
- •Cardiovascular related:
- •22. History of heart failure with reduced left ventricular ejection fraction (LVEF) defined as any past measurement of LVEF = 40%
- •23. N-terminal-prohormone B-type natriuretic peptide (NT-proBNP) >900 pg/mL
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