EUCTR2016-004566-26-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis - STELLARIS
Tobira Therapeutics, a subsidiary of Allergan plc0 个研究点目标入组 2,000 人开始时间: 2017年3月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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. Male and female subjects aged between 18-75 years
- •2. Ability to understand and sign a written informed consent form (ICF)
- •3. Histological evidence of NASH based on central reading of the biopsy slides
- •4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides
- •5. Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug.
- •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 1800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Inability to undergo a liver biopsy
- •2. Hepatitis B surface antigen (HBsAg) positive
- •3. Hepatitis C antibody (HCVAb) positive
- •4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
- •5. Prior or planned liver transplantation
- •6. Other known causes of chronic liver disease
- •7. History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- •8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
- •9. AST > 200 IU/L in males and females at Screening
- •10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening
- •11. HbA1c > 10% at Screening
- •12. Serum albumin < 3.5 g/dL
- •13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
- •14. Platelet count < 100,000/mm3
- •15. Total bilirubin > 1.5 mg/dL (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor)
- •16. International normalized ratio (INR) > 1.3
- •17. Model of end stage liver disease (MELD) score > 12
- •18. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
- •19. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
- •20. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
- •21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
- •22. Females who are pregnant or breastfeeding
- •23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons)
- •24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the liver biopsy at Screening
- •25. Receiving ongoing therapy with any disallowed medication between Screening and Baseline visits.
- •26. Allergy to the study drug or its components
- •27. Receiving any investigational products within 30 days prior to Screening or anticipated use during the trial
- •28. Participated in a clinical trial with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 12 months before Day 1
- •29. Participation in any other clinical trial at Screening without approval from the sponsor
- •30. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements
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