EUCTR2012-000295-42-IT进行中（未招募）不适用
A Study to Evaluate the Efficacy and Safety of GFT505 once daily onSteatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).A Multicentre, Randomized, Double Blind, Placebo-Controlled study, withan adaptive design to allow for initial GFT505 80mg dosing versus placebo,followed by a second phase including GFT505 120mg dose, after review of6-month safety analysis of the 80mg data on at least 50% of patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GENFIT SA
- 入组人数
- 270
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. Provide written informed consent prior to enrolment. 2. Males or females able to read. 3. Females participating in the study must be either of non-child bearing potential (surgically sterilized at least 6 months prior to screening or postmenopausal) or using an efficient double contraception: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device or other mechanical contraception method + condom or diaphragm or spermicide for all the duration of the study. 4. Aged from 18 to 75 years inclusive at screening. 5. BMI = 45 kg/m². 6. Patients agree to have one liver biopsy during the screening period for diagnostic purpose (if no historical biopsy within 6 months before randomization is available) and one at the end of the treatment period for assessment of the treatment effects. 7. For hypertensive patients, hypertension must be 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). 8. Patients treated with vitamin E (>400UI/d), or PUFAs (>2g/day) or Ursodeoxycholic acid can be included if drugs are stopped at least 3 months prior to diagnostic liver biopsy and up to the end of the study. 9. Histological confirmation of steatohepatitis on a diagnostic liver biopsy (biopsy obtained within 6 months prior to randomization or during the screening period). Histological diagnostic is confirmed by central reading of the slides (steatosis > 5% + lobular inflammation, any grade + ballooning, any amount). 10. For patients with Type 2 Diabetes, glycemia must be controlled (HbA1c=8.5%). If glycemia is controlled by anti-diabetic drugs, qualitative change (i.e. implementation of a new antidiabetic drug) is not permitted within 6 months prior to randomization and should be avoided during the study. Treatments with metformin, DPPIV inhibitors, GLP1 agonists, sulfamides, insulin are authorised. Sulfamides and insulin are permitted if glycemia is self-monitored by the patient. 11. Patients agree to come to the study visits within the protocolspecified delay.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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 70
排除标准
- •1.Known heart failure (Grade I to IV of NYHA classification).2.Weight loss of more than 5% within 6 months prior to random.3. History of bariatric surgery.4.Uncontr.Blood Pressure (SBP> 160mmHg and/or DBP>95 mmHg).5.Type 1 diab.pts. 6.Pts who had an acute cardiov. episode within the 6 months prior to screening,or with a history of coronary angioplasty,hist.of stroke,TIA (Transient Ischemic Attack),Coronary Heart Disease (Angina pectoris,myocardial infarction,revascularisation procedures). 7.Compensated and uncompensated cirrhosis(clinical and/or histological evidence of cirrhosis).Notably,NASH pts with fibrosis stage=4 acc.to the NASH CRN fibrosis staging system are excluded.8.Known alcohol and/or any other drug abuse or dependence in the last 5 years.Alcohol consumption of more than 2 drink units/day for women and 3 drink units/day for men is considered abusive.One drink unit is defined as 30mL distilled spirits,120mL wine,or 330mL beer.9.Pts who have donated blood or blood prod.within the previous month prior to screening or who plan to donate blood or blood prod.at any time during the trial and in the 3 months following the end of the study.10.Pregnant or lactating females.11.Other well documented causes of chronic liver disease acc.to standard diagnostic proced.including, but not restricted to: pos.HBsAg, pos.HCV RNA,suspicion of drug-induced liver disease,autoimmune hepatitis, Wilson's disease,primary biliary cirrhosis,primary sclerosing cholangitis,genetic hemochromatosis documented by homozygosity for the C282Y HFE gene mutation.12.Pts not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.13.When applicable and according to National Law in force, patient of legal age unable of giving consent or under legal protection or deprived of freedom by judicial or administrative decision.14.Pts who cannot be contacted in case of emergency.15.Known intolerance or contra-indication to the list of excipients of GFT505.16.Pts are currently participating in,plans to participate in,or have partic.in an investig.drug or medical device trial within 30 days or five half-lives,whichever is longer,prior to screening.17.Glitazones (rosiglitazone and pioglitazone) are not permitted 6 months before diagnostic liver biopsy and up to the end of the study.18.Non-statin lipid-lowering medications such as fibrates are not permitted 8 weeks before randomization and up to the end of the study. Non-statin lipid lowering medications can be washed-out during the screening period. Patients that used statins before screening may participate if the dosage has been kept constant for the past 3 months, and is kept constant and stable during the study. 19. Vitamin E (>400UI/day), PUFAs (>2g/day) and Ursodeoxycholic acid should have been stopped 3 months before diagnostic liver biopsy (and can be washed-out during the screening period in case of no available historical biopsy). They are not permitted up to the end of the study. 20. Currently taking drugs that can induce Steatosis/steatohepatitis: corticosteroids (parenteral administration only), amiodarone (Cordarone), Tamoxifen (Nolvadex), methotrexate (Rheumatrex, Trexall). 21. Currently taking any medication that could interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomal enzymes. 22. Evidence of any other unstable or, untreated clinica
研究者
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH). A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients.accumulation of fat in liver associated with inflammation and liver cell injury.Non-Alcohilic Steatohepatitis (NASH)10000546NL-OMON39848GENFIT15
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of GFT505 80 mg and GFT505 120 mg daily for 52 weeks in Patients with Non-Alcoholic Steatohepatitis (accumulation of fat in the liver associated with inflammation and liver cell injury at microscopic examination of liver biopsy).Patients with Non-Alcoholic Steatohepatitis (NASH)MedDRA version: 15.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2012-000295-42-ESGENFIT270
终止
4 期
A Prospective Study on Efficacy and Safety of Filgrastim (Leuco-Plus 300) for Prevention of Chemotherapy Induced Neutropenia in Patients with Diffuse Large B-Cell LymphomaPatients with Diffuse Large B-Cell LymphomaCHOPR-DLBCLTCTR20170802002Apexcela Co., Ltd.20
已完成
4 期
A Pilot Study to Evaluate Efficacy and Safety of Fixed Dose Combination Capsules in Patients with GERD and Overlapping Symptoms of DyspepsiaCTRI/2020/09/027876Abbott India limited50
招募中
2 期
A observational study for safety and efficacy of Fulvestrant 500mg in postmenopausal patients with ER positive advanced or recurrent breast cancer after prior endocrine treatment. (SBCCSG-29)ocally advanced or metastatic breast cancerJPRN-UMIN000009110Saitama Breast Cancer Clinical Study Group(SBCCSG)100