EUCTR2021-000007-21-CZ进行中（未招募）1 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). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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:
- •Sex and Age
- •1. Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
- •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 who have proven PBC, as demonstrated by historically having at least 2 of the following:
- •Documented history of sustained increased ALP levels greater than 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 initiation of UDCA therapy).
- •Documented positive anti-mitochondrial antibody (AMA) titer (>1:40 titer on immunofluorescence or M2 positive by enzyme linked immunosorbent assay [ELISA]) or PBC-specific antinuclear antibodies (antinuclear dot and/or nuclear rim positive).
- •Liver biopsy (documented at any time in the past) consistent with PBC.
- •3. Participants who, during the Screening period, record their daily itch score by entering at least 40 of the 56 required itch entries, with an entry on at least 4 days in each week, during the 4-week period immediately preceding Randomization at Day 1 and have a Monthly Itch Score of =4 (i.e., at least 1 of the 4 weekly Mean Worst Daily Itch Scores must be =4), and no Mean Worst Daily Itch Score can be <3 for any other week.
- •Contraceptive/Barrier 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:
- •-Is a woman of non-childbearing potential (WONCBP)
- •-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.
- •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 8.2.5 Pregnancy Testing.
- •Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.5.
- •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 Section 10.1 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 175
- •F.1.3 Elderly (>=65
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. Participants with recent positive COVID-19 test results, symptoms suggestive of active COVID-19 infection (e.g. fever, loss of taste or smell, cough, shortness of breath) and/or contact within the past 14 days with someone with COVID-19 are excluded for a minimum of 14 days from the test results or time of exposure, respectively, and must be symptom free before Screening procedures may begin. If a participant tests positive for COVID-19 during the Screening period, the participant should be considered a screen failure and may be re-screened 14 days after the positive test result and after participant is symptom free.
- •2. Total bilirubin >2.0 x ULN using the average of two baseline measures. Note: Total bilirubin > 2x ULN but < 3x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%
- •3. Screening ALT > 6x ULN in a single baseline measure or ALT > 5x ULN using the average of two baseline measures.
- •4. Participants with abnormal liver biochemistry (ALT, aspartate aminotransferase [AST], ALP, or total bilirubin) during the Screening period (at Visit 1 or Visit 2) and the variance between these two samples for the abnormal parameter is >40%. Note: Variance will be calculated as the absolute value of [(Sample 1- Sample 2)/average of Sample 1 and Sample 2) x100] If variance of >40% is seen between Visit 1 and 2 samples, an additional sample may be taken and the variance between the additional sample (third sample) and the Screening (Visit 1) sample must be = 40%
- •5. Screening estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •6. History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).
- •7. 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.
- •8. Infection with human immunodeficiency virus (HIV)
- •9. Current clinically significant diarrhea in the Investigator’s medical opinion.
- •10. Active inflammatory ileal disease according to Investigator´s clinical judgment.
- •11. Current symptomatic cholelithiasis or cholecystitis. (Participants with history of cholecystectomy =12 weeks before screening may be eligible for enrolment at the discretion of the investigator.)
- •12. Current diagnosis of primary skin disorders with itch symptoms (e.g., atopic dermatitis, psoriasis).
- •13. Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia
- •14. Any current malignancies (including hematologic and solid malignancies).
- •15. Current/previous diagnosis of colorectal cancer.
- •16. History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years
- •17. Any current uncontrolled psychiatric condition
- •18. Any current medical condition (e.g. senility or dementia), which may affect the participant’s ability to comply with the protocol specified procedures.
- •Prior/Concomitant Therapy
- •19. Initiation, discontinuation or change in dose of UDCA in the 8 weeks prior to Screening. (Participants may join the study on stable doses of UDCA, but no initiation, discontinuation, or change in dose is permitted until completion of the Treatment Periods.)
- •20. Use of obeticholic acid: withi
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