NCT04167358进行中（未招募）3 期
Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 242
- 试验地点
- 94
- 主要终点
- Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
研究概览
简要总结
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open label non-comparator study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Participants receiving linerixibat
Experimental
Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
干预措施: Linerixibat (Drug)
结局指标
主要结局
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
时间窗: Up to 66 months
AEs and SAEs will be collected.
Number of participants with Severe AEs
时间窗: Up to 66 months
AEs and SAEs will be collected.
次要结局
- Change in self-rated health by EQ VAS scores over time (Group 1 only)(Baseline and up to 65 months)
- Change in domain scores of the PBC-40 over time(Baseline and up to 65 months)
- Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)(Baseline and up to 65 months)
- Change in the Beck Depression Inventory (BDI-II) scores over time(Baseline and up to 65 months)
- Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)(Baseline and up to Week 52 of continuous treatment)
- Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters(Baseline and up to 65 months)
- Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)(Week 24 and Week 52 of continuous treatment)
- Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)(Baseline and up to Week 52 of continuous treatment)
- Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)(Week 52 of continuous treatment)
研究者
研究点 (94)
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