EUCTR2016-002416-41-ES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).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 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 during the 8 weeks prior to the Screening Visit.
- •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 >1.5x ULN. Isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
- •2. Screening ALT or aspartate aminotransferase (AST) >4x 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. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune hepatitis, biopsy proven non-alcoholic steatohepatitis (NASH) or confirmed hepatocellular carcinoma.
- •6. Current symptomatic inflammatory bowel disease, chronic diarrhea, Crohn’s disease or diarrhea related to malabsorption syndromes.
- •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. Administration of the following drugs at any time during the 3 months prior to screening for the study or planned administration during the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids.
- •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.
- •Prior/Concurrent Clinical Study Experience
- •14. Current enrollment or participation within the 8 weeks before start of the Initial Study Period, in any other clinical study involving an investigational study treatment.
- •Diagnostic assessments
- •15. QTc >450 msec or QTc >480 msec in participants with bundle branch block:
- •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 discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an indivi
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