EUCTR2019-003158-10-BE进行中（未招募）1 期
ong-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 295
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 the
- •following criteria apply:
- •1. Male or female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent study BAT117213, GLIMMER or GLISTEN
- •Note: if country/site age requirements for consent differ, the more stringent (e.g., higher age) restriction will be required for that country/site.
- •Type of Participant and Disease Characteristics
- •2.Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical study(BAT117213, GLIMMER or GLISTEN)
- •3.Participants must have completed the main treatment period(s) in a prior eligible linerixibat clinical study (BAT117213, GLIMMER or GLISTEN)
- •Contraception requirements
- •4.Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- •o Is a woman of non-childbearing potential (WONCBP)
- •o Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in Section 10.4 during the study intervention period (at a minimum until 4 weeks after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in
- •relationship to the first dose of study intervention, etc.).
- •-A WOCBP must have a negative highly sensitive urine pregnancy test (or serum, as required by local regulations) within 7 days before the first dose of study intervention, see Section 10.4 Pregnancy Testing.
- •o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
- •Additional requirements for pregnancy testing during and after study intervention are listed in Section 8.2.5 Pregnancy Testing and Section 10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Note: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Full requirements for pregnancy testing during and after study intervention are located in Section 10.4 Appendix 4.
- •Informed Consent
- •5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Participants are excluded from the study if any of the following criteria
- •Medical Conditions
- •1.Screening total bilirubin >2x ULN.
- •Notes: Total bilirubin >2x ULN but <3x ULN is acceptable if bilirubin is
- •fractionated and direct bilirubin is <35%
- •2.Screening ALT or aspartate aminotransferase (AST) >6x ULN
- •3.Screening estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- •4. Group 2 Participants who meet increased liver chemistry monitoring criteria or any stopping criteria during LLSAT Screening period (GLISTEN Week 28 to Week 32 visit) or temporarily discontinue study treatment due to a drug-related adverse event during the LLSAT Screening period, which is ongoing before Baseline Visit.
- •Note: participants that meet increased liver chemistry monitoring criteria or stopping criteria at any timepoint during GLISTEN and restart of study intervention has not been approved by GSK are excluded
- •5. Presence of hepatic decompensation (e.g., variceal bleeding, encephalopathy or ascites)
- •6. 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
- •7. Current clinically significant diarrhea in the Investigator's medical opinion
- •8. Current symptomatic cholelithiasis or cholecystitis. Participants with history of cholecystectomy =3 months before screening may be eligible for enrollment
- •9. Current diagnosis or previous diagnosis of colorectal cancer
- •10. Any current malignancies (including hematologic and solid malignancies).
- •11. History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
- •12. 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
- •13. 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. [Rationale: The potential for a Drug-Drug Interaction (DDI) between obeticholic acid and linerixibat is under investigation. A DDI study assessing the concomitant use of OCA and 40 mg linerixibat twice daily is planned and depending on those results this
- •OCA exclusion may be removed]
- •14. Administration of any other IBAT inhibitor in the 1 month prior to screening until after End of Study or Early study withdrawal [Rationale: Effects of another IBAT inhibitor may confound interpretation of the linerixibat safety and tolerability profile]
- •Prior/Concurrent Clinical Study Experience
- •15. Current enrollment or participation in any other clinical study (except for GLISTEN) involving an investigational study treatment within 8 weeks prior to the screening visit
- •Note: For participants coming from the GLISTEN study there is no specified waiting period before enrollment into this safety study.
- •Diagnostic Assessments
- •16. QTc >480 msec at screening (12-lead ECG)
- •Notes: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Frederica'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 and maintained for individ
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