A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS) - VLX-301

Mirum Pharmaceuticals Inc.0 个研究点目标入组 395 人开始时间: 2023年5月25日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period., Age =12 years for eligible regions; otherwise =18 years, Have a confirmed PSC diagnosis prior to Visit 2 consistent with the guidelines for the diagnosis and management of PSC published by the AASLD, Average daily Adult ItchRO score =1 during the 2 consecutive weeks leading to Visit 2, Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria., Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria

•Chronic pruritus of other etiology other than that may interfere with the severity assessment of PSC-related pruritus, Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events., Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening, History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation., Evidence, history, or suspicion of other liver and GI-related diseases and malignancies., History of liver transplantation, Exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR),serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin

发起方