A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis

Gilead Sciences, Inc.0 个研究点目标入组 52 人开始时间: 2016年12月21日最近更新: 2020年6月15日

适应症

试验速览

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•-Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography [MRCP], endoscopic retrograde cholangiopancreatography [ERCP], or percutaneous transhepatic cholangiogram [PTC]) within the previous 12 months;
•-Serum ALP > 1.67 x ULN;
•-For subjects on ursodeoxycholic acid (UDCA), the dose of UDCA must have been stable for at least 12 months prior to screening through the end of treatment. For subjects not on UDCA, no UDCA use for at least 12 months before screening through the end of treatment;
•-For subjects being administered biologic treatments (eg, antitumor necrosis factor [TNF] or anti-integrin monoclonal antibodies), immunosuppressants or systemic corticosteroids, the dose must have been stable at least 3 months prior to screening and anticipated to remain stable throughout the trial;
•-Screening FibroSURE/FibroTest® <0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In subjects with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin.
•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 43
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•-ALT > 10x ULN;
•-Total bilirubin > 2x ULN;
•-INR > 1.2 unless on anticoagulant therapy;
•-Serum albumin < 3.3 g/dL;
•-Cirrhosis of the liver as defined by any of the following:
•a) Historical liver biopsy demonstrating stage 4 fibrosis (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 > 14.4 kPa by FibroScan®
•-Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography);
•-Other causes of liver disease including secondary sclerosing cholangitis and 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;
•-Ascending cholangitis within 60 days of screening;
•-Presence of a percutaneous drain or bile duct stent;
•-Use of fibrates or obeticholic acid within 3 months prior to screening and through the end of treatment;
•-Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of > 1 and/or a score on the Rectal Bleeding Domain > 0.

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