EUCTR2016-004566-26-BE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 - AURORA
Tobira Therapeutics Inc., a subsidiary of Allergan plc0 个研究点目标入组 2,000 人开始时间: 2017年3月13日最近更新:
适应症
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 screening liver biopsy slides
- •4. Subjects included in Part1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides. Subjects newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period 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 safely
- •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 (NASH CRN Fibrosis Stage 4) 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 > 5 × upper limit of normal (ULN) at Screening
- •10. ALT > 5 × ULN at Screening
- •11. HbA1c > 9% 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 at Screening
- •14. Platelet count < 100,000/mm3 at Screening
- •15. Total bilirubin > 1.3 mg/dL (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor) at Screening
- •16. International normalized ratio (INR) > 1.3
- •17. Model of end stage liver disease (MELD) score > 12
- •18. Weight reduction, defined as = 7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
- •19. Known history of hepatocellular carcinoma (HCC) at any time, history of malignancy within the past 5 years or ongoing malignancy other than: basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated stage II or lower colorectal or breast cancer in remission for = 2 years and with documented low risk of recurrence (including but not limited to Oncotype DX 12 gene recurrence score <30 for stage II or lower colon cancer; early-stage, estrogen-receptor-positive, HER2-negative breast cancers that have not spread to the lymph nodes; Oncotype DX 21 gene recurrence score <18 for early stage invasive breast cancer; or Oncotype DX ductal carcinoma in situ [DCIS] 12 gene recurrence score <39 for noninvasive breast cancer)
- •20. Active, serious infections that require parenteral therapy (antibiotic or antifungal) 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 immune-modulating 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) and/or SGLT1 inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Subjects on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, subjects need to be on stable therapy for at least 6 months prior to the day historical liver biopsy) was performed).
- •25. Receiving ongoing therapy with any disallowed medication during the conduct of the study. Disallowed medication in use prior to
- •enrollment will be required to be discontinued. For medications that are disallowed due to significant drug interactions with
研究者
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