EUCTR2016-002443-42-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Biliary Cholangitis Without Cirrhosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Meets all of the following conditions;
- •a) Definite or probable PBC as defined by at least 2 of the 3 following criteria:
- •i. Serum alkaline phosphatase (ALP) > the upper limit of normal (ULN)
- •ii. Presence of anti-mitochondrial antibodies (AMA) in serum (= 1:40 on immunofluorescence)
- •iii. Liver histological (based on historic liver biopsy) findings consistent with PBC including nonsuppurative, destructive cholangitis affecting mainly the interlobular bile and septal bile ducts;
- •b) Serum ALP >1.67 x ULN and/or total bilirubin >ULN but = 2x ULN;
- •c) UDCA use at a stable dose for at least 12 months prior to screening through the end of treatment or intolerant of UDCA with no UDCA use for at least 12 months before screening through the end of treatment;
- •-Screening FibroSURE/FibroTest® <0.75.
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •-ALT > 5x ULN;
- •-Total bilirubin > 2x ULN;
- •-INR >1.2 unless on anticoagulant therapy;
- •-Other causes of liver disease including viral, metabolic, alcoholic, and other autoimmune conditions. Subjects with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy;
- •-Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment;
- •-Cirrhosis of the liver as defined by any of the following:
- •a) Historical liver biopsy demonstrating cirrhosis (e.g. Ludwig stage 4 or Ishak stage =5)
- •b) History of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
- •c) Liver stiffness >16.9 kPa by FibroScan®
研究者
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