EUCTR2021-000007-21-IT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
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 230 人开始时间: 2021年8月17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
- 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:
- •o Is not a woman of non-childbearing potential
- •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.
- •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 years) yes
- •F.1.3.1 Numbe
排除标准
- •1. Participants with symptoms suggestive of active COVID-19 infection (i.e. fever,cough, loss of taste or smell etc.) are excluded whilst symptoms persist.
- •2. Total bilirubin >2.0 x ULN using the average of two baseline measures.
- •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%.
- •5. Screening estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 based on 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.
- •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,narcoleptsy,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
- •20. Use of obeticholic acid: within 8 weeks prior to Screening
- •21. Initiation, discontinuation or change in dose of bezafibrate or fenofibrate at any time during the 8 weeks prior to Screening.
- •22. Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other SSRIs.
- •23. Initiation, discontinuation or change in dose of opioids, regardless of indication, in the 8 weeks prior to Screening.
- •24. Initiation, discontinuation or change in dose of colchicine, methotrexate ,azathioprine, or systemic corticosteroids in the 8 weeks prior to Screening
- •25. Initiation, discontinuation, or change in dose of antihistamines used for the treatment of itching the 8 weeks prior to Screening.
研究者
相似试验
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)EUCTR2021-000007-21-BEGlaxoSmithKline Research & Development Limited230
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)EUCTR2021-000007-21-CZGlaxoSmithKline Research & Development Limited230
进行中（未招募）
1 期
Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN)Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).MedDRA version: 24.1Level: PTClassification code 10064190Term: Cholestatic pruritusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 27.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2021-000007-21-GRGlaxoSmithKline Research & Development Limited230
招募中
3 期
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)JPRN-jRCT2071210048Okawa Yasutoshi25
进行中（未招募）
1 期
Safety and pharmacokinetics of FBR-002 for the treatment of patients hospitalized with COVID-19 need of supplemental oxygen and at risk of severe outcomeCOVID-19 in hospitalized patients in need of supplemental oxygen and at risk of severe outcomeMedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2021-002390-25-GRFab'entech30