EUCTR2016-002416-41-IT进行中（未招募）1 期
A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). - Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cho
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 147 人开始时间: 2020年12月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2. Participants who have proven PBC, as demonstrated by having at least 2 of the following:
- •History of sustained increased ALP levels >upper limit of normal (ULN) first recognized at least 6 months prior to the Screening Visit (Note: Sustained ALP elevations at the time of Screening is not required, recognizing that the ALP may have decreased after institution of UDCA therapy as described in inclusion number 4).
- •Documented positive anti-mitochondrial antibody (AMA) titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and/or nuclear rim positive).
- •Liver biopsy (at any time in the past) consistent with PBC.
- •3.Participants must rate their itch severity as being =4 on a 0 to 10-point scale for
- •the majority of time (at least half the days, as recalled by the participant) during
- •the 8 weeks prior to the Screening Visit. Periods of low itch or no itch are
- •acceptable as long as the worst daily itch score is =4 on the majority of days.
- •4. Participants who are currently taking UDCA should be on stable doses of UDCA for >8 weeks at time of screening. Participants not taking UDCA due to intolerance may be enrolled 8 weeks after their last dose of UDCA.
- •Note: no changes or discontinuation is permitted until completion of the Main Study Period.
- •5. Male and/or female:
- •a. Female participants:
- •A female participant is eligible to participate if she is not pregnant (see Appendix 2 of study protocol), not breastfeeding, and at least one of the following conditions applies:
- •(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 of study protocol
- •(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 of study protocol during the treatment period and until at least 4 weeks after the last dose of study treatment.
- •Informed Consent
- •6. Capable of giving signed informed consent as described in Appendix 3 of study protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. Screening total bilirubin >2x ULN. Isolated bilirubin >2x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
- •2. Screening ALT or aspartate aminotransferase (AST) >6x ULN.
- •3. Screening estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
- •5. Presence of actively replicating viral hepatitis B or C (HBV, HCV) infection and/or confirmed hepatocellular carcinoma or biliary cancer.
- •Note: Other hepatic conditions (e.g., primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis [NASH] are permitted if PBC is the dominant liver injury in the investigator’s opinion.
- •6. Current diarrhea.
- •7. Current symptomatic cholelithiasis or inflammatory gall bladder disease. Participants with history of cholecystectomy =3 months before screening may be eligible for enrollment.
- •8. Any current medical condition (e.g. psychiatric disorder, senility or dementia), which may affect the participant’s ability to comply with the protocol specified procedures.
- •Prior/Concomitant Therapy
- •9. Initiation or increase in dose of colchicine, methotrexate, azathioprine, or systemic corticosteroids in the 2 months prior to screening.
- •Note: If a change in dose in any of these medications is anticipated during the course of the study, the participant should be excluded. [Rationale: Limited evidence indicates these drugs may alter disease progression in some PBC patients.]
- •10. Initiation or increase in dose of bezafibrate or fenofibrate at any time during the 3 months prior to screening. Participants may join the study on stable doses of these medications, but no change or discontinuation is permitted until completion of the Main Study Period.
- •11. Initiation or increase in dose of any of the following in the 8 weeks prior to screening: rifampicin, naltrexone, naloxone, nalfurafine, or sertraline. Participants may join the study on stable or decreased doses of these medications, but no change in dose is permitted until completion of the Main Study Period.
- •12. Bile acid binding resin use: a participant must discontinue use of cholestyramine, colesevelam, colestipol or colestimide prior to the start of the Initial Study Period (no later than Day -2). Note: these drugs may be administered after completion of the Main Study Period, if clinically indicated.
- •13. Obeticholic acid use: a participant must discontinue use of obeticholic acid at least 8 weeks prior to the start of the Initial Study Period and may not restart until after the end of the study.
- •14. Administration of any other IBAT inhibitor in the 3 months prior to screening [Rationale: Effects of another IBAT inhibitor may influence pruritus.]
- •Prior/Concurrent Clinical Study Experience
- •15. Current enrollment or participation within the 8 weeks before start of the Initial Study Period, in any other clinical study involving an investigational study
- •Diagnostic assessments
- •16. QTc >480 msec
- •- The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is
- •either machine-read or manually over-read.
- •- The specific formula used to determine eligibility and discon
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