EUCTR2015-004336-35-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
入选标准
- •1. Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
- •2. Histological evidence of definite NASH based on NASH CRN criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1
- •3. NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
- •4. Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System
- •a. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome
- •5. Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
- •6. If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)
- •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 264
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1. Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator?s judgement
- •2. Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses
- •3. Uncontrolled diabetes (glycated hemoglobin [HbA1c] ?9%) within 60 days prior to Day 1
- •4. Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading)
- •5. Evidence of other forms of chronic liver disease such as:
- •a. autoimmune hepatitis
- •b. active infection with hepatitis B virus (HBV)
- •c. hepatitis C virus (HCV) infection
- •d. primary biliary cirrhosis
- •e. primary sclerosing cholangitis
- •f. Wilson?s disease
- •g. alpha-1-antitrypsin deficiency
- •h. hemochromatosis or iron overload
- •i. drug-induced liver disease
- •j. other biliary liver disease
- •6. ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert?s as documented in the medical records)
- •7. Alpha-fetoprotein >100 ng/mL
- •8. Hemoglobin <10 g/L
- •9. White blood cell (WBC) count <3.0 × 109/L
- •10. Severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 50 mL/min/1.73 m2
- •11. Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters (atazanavir, cyclosporine, eltrombopag,
- •gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications)
- •12. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months
- •13. Inability to safely obtain a liver biopsy
- •14. Known human immunodeficiency virus (HIV) infection
- •15. Any subject who has made a significant lifestyle change to their diet and/or exercise regimens within 3 months prior to Day 1 or plans to do so during the study
- •16. Abuse of controlled substances (including inhaled or injected drugs) or nonprescribed use of prescription drugs within 1 year of screening
- •17. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
- •18. Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening
- •19. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval >480 milliseconds (msec)
- •20. Prior or pla
研究者
相似试验
进行中（未招募）
1 期
A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyCrohn's Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-001226-18-CZAbbVie Deutschland GmbH & Co. KG645
进行中（未招募）
1 期
A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2018-002303-33-BECB Biopharma SR625
招募中
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancernon-spread Castration-Resistant Prostate Cancer10036958NL-OMON54510Aragon Pharmaceuticals, Inc.35
进行中（未招募）
1 期
A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseEUCTR2019-002531-29-GBVisterra, Inc.144
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.Type 2 Diabetes MellitusEUCTR2009-010224-25-HUBristol-Myers Squibb International Corporation152