JPRN-jRCT2071210048招募中3 期
A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC) - GLISTE
Okawa Yasutoshi0 个研究点目标入组 25 人开始时间: 2021年7月30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
- 25
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 between 18 to 80 years of age inclusive, at the time of signing the informed consent.
- •- Participants who have documented PBC.
- •- Participants who have moderate to severe itch.
排除标准
- •Symptoms suggestive of active coronavirus disease 2019 (COVID-19) infection whilst symptoms persist or known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days from the exposure.
- •Total bilirubin >2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures.
- •Screening Alanine Aminotransferase (ALT) > 6 times ULN in a single Baseline measure or ALT > 5 times ULN using the average of two Baseline measures.
- •Screening estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (mL/min/1.73m(hat[symbol])2).
- •History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).
- •Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
- •Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator's clinical judgment.
- •Current symptomatic cholelithiasis or cholecystitis.
- •Current diagnosis of primary skin disorders with itch symptoms (e.g., atopic dermatitis, psoriasis).
- •Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.
- •Current/previous diagnosis of colorectal cancer.
- •Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening.
- •Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study).
- •Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching.
- •Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening.
- •Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study.
- •History of sensitivity or intolerance to the study treatment.
研究者
相似试验
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)EUCTR2021-000007-21-BEGlaxoSmithKline Research & Development Limited230
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)EUCTR2021-000007-21-CZGlaxoSmithKline Research & Development Limited230
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)EUCTR2021-000007-21-ITGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT230
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).MedDRA version: 24.1Level: PTClassification code 10064190Term: Cholestatic pruritusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 27.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2021-000007-21-GRGlaxoSmithKline Research & Development Limited230
已完成
不适用
A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male SubjectsNL-OMON46723Janssen-Cilag International NV52