EUCTR2019-003158-10-PL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
- 75
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 trial
- •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 trial(BAT117213, GLIMMER or GLISTEN)
- •3. Participants must have completed the main treatment period(s) in a
- •prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN)
- •Contraception requirements
- •4. Contraceptive use by women should be consistent with local
- •regulations regarding the methods of contraception for those
- •participating in clinical studies. Contraception by male participants or
- •male partners of female participants is not required in this protocol
- •-A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •o Is not a woman of childbearing potential (WOCBP)
- •o Is a WOCBP and using a contraceptive method that is highly effective
- •(with a failure rate of <1% per year), with low user dependency, as
- •described in Appendix 4 of Protocol, during the intervention period and
- •for at least 4 weeks, after the last dose of study intervention. The
- •investigator should evaluate the effectiveness of the contraceptive
- •method in relationship to the first dose of study intervention
- •-A WOCBP must have a negative highly sensitive pregnancy test (urine
- •or serum as required by local regulations) within 24 hours before the
- •first dose of study intervention
- •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 Appendix 4: Contraceptive Guidance and
- •Collection of Pregnancy Information of Protocol
- •-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
- •-Informed Consent
- •5. Capable of giving signed informed consent as described in Appendix 1
- •of protocol, which includes compliance with the requirements and
- •restrictions listed in the informed consent form (ICF) and in this
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Participants are excluded from the study if any of the following criteria
- •Medical Conditions
- •1. Screening total bilirubin >2x ULN.
- •Note: 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. History or presence of hepatic decompensation (e.g., variceal
- •bleeding, encephalopathy or ascites)
- •5. 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
- •6. Current clinically significant diarrhea in the Investigator's medical
- •7. Current symptomatic cholelithiasis or cholecystitis. Participants with
- •history of cholecystectomy =3 months before screening may be eligible
- •for enrollment
- •8. Current diagnosis or previous diagnosis of colorectal cancer
- •9. Any current malignancies (including hematologic and solid
- •malignancies).
- •10. History of bariatric surgery with ileal bypass at any time, or any
- •bariatric surgery performed in the past 3 years.
- •11. 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
- •12. 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
- •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]
- •13. Administration of any other IBAT inhibitor in the 1 month prior to
- •screening [Rationale: Effects of another IBAT inhibitor may confound
- •interpretation of the linerixibat safety and tolerability profile]
- •Prior/Concurrent Clinical Study Experience
- •14. 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
- •15. 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
- 另有 10 项未显示
研究者
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