JPRN-jRCT2080225120招募中3 期
ong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis
GlaxoSmithKline K.K.0 个研究点目标入组 305 人开始时间: 2020年3月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 305
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
- •Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- •Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
- •Capable of giving signed informed consent.
排除标准
- •Screening total bilirubin >2x upper limit of normal (ULN).
- •Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
- •Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
- •Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV], viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
- •Current clinically significant diarrhea in the Investigator's medical opinion.
- •Current symptomatic cholelithiasis or cholecystitis.
- •Current diagnosis or previous diagnosis of colorectal cancer.
- •Any current malignancies (including hematologic and solid malignancies).
- •History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
- •Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
- •Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
- •QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
- •Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.
研究者
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