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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003158-10 | EudraCT Number |
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This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving linerixibat | Experimental | Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linerixibat | Drug | All participants will receive linerixibat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs) | AEs and SAEs will be collected. | Up to 66 months |
| Number of participants with Severe AEs | AEs and SAEs will be collected. | Up to 66 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in domain scores of the PBC-40 over time | The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Davis | California | 95817 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
This is a non-comparator single group study.
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This is an open label non-comparator study.
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| Baseline and up to 65 months |
| Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only) | The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems. | Baseline and up to 65 months |
| Change in self-rated health by EQ VAS scores over time (Group 1 only) | The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. | Baseline and up to 65 months |
| Change in the Beck Depression Inventory (BDI-II) scores over time | The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression. | Baseline and up to 65 months |
| Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters | Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters. | Baseline and up to 65 months |
| Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only) | Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (>=) 2, >=3, and >=4-point reduction in MIS will be assessed. | Week 24 and Week 52 of continuous treatment |
| Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only) | The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (>=2, >=3, and >=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment. | Week 52 of continuous treatment |
| Change from Baseline Monthly Sleep Score (MSS) (Group 2 only) | The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment. | Baseline and up to Week 52 of continuous treatment |
| Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only) | The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment. | Baseline and up to Week 52 of continuous treatment |
| West Hollywood |
| California |
| 90048 |
| United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Detroit | Michigan | 48377 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Morrisville | North Carolina | 27560 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Dallas | Texas | 75390 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Seattle | Washington | 98105 | United States |
| GSK Investigational Site | Buenos Aires | C1061AAS | Argentina |
| GSK Investigational Site | Capital Federal | C1181ACI | Argentina |
| GSK Investigational Site | Ciudad AutOnoma de Buenos Aire | 1118 | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Bueno | C1056ABI | Argentina |
| GSK Investigational Site | Rosario | S2002KDT | Argentina |
| GSK Investigational Site | Santa Fe | 3000 | Argentina |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
| GSK Investigational Site | Botucatu | 18618686 | Brazil |
| GSK Investigational Site | Brasília | 70335-900 | Brazil |
| GSK Investigational Site | Salvador | 40110-160 | Brazil |
| GSK Investigational Site | Sofia | 1618 | Bulgaria |
| GSK Investigational Site | Edmonton | Alberta | T6G 2X8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| GSK Investigational Site | Beijing | 100032 | China |
| GSK Investigational Site | Beijing | 100069 | China |
| GSK Investigational Site | Changchun | 130021 | China |
| GSK Investigational Site | Chongqing | 400042 | China |
| GSK Investigational Site | Guangzhou | 510630 | China |
| GSK Investigational Site | Nanchang | 330006 | China |
| GSK Investigational Site | Nanjing | 210003 | China |
| GSK Investigational Site | Shanghai | 200127 | China |
| GSK Investigational Site | Tianjin | 300000 | China |
| GSK Investigational Site | Pilsen | 30100 | Czechia |
| GSK Investigational Site | Prague | 140 21 | Czechia |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Erlangen | 91054 | Germany |
| GSK Investigational Site | Münster | 48149 | Germany |
| GSK Investigational Site | Haifa | 34362 | Israel |
| GSK Investigational Site | Holon | 58100 | Israel |
| GSK Investigational Site | Jerusalem | 91120 | Israel |
| GSK Investigational Site | Rehovot | 76100 | Israel |
| GSK Investigational Site | Milan | 20142 | Italy |
| GSK Investigational Site | Modena | 41126 | Italy |
| GSK Investigational Site | Monza | 20900 | Italy |
| GSK Investigational Site | Naples | 80131 | Italy |
| GSK Investigational Site | Negrar Verona | 37024 | Italy |
| GSK Investigational Site | Padova | 35128 | Italy |
| GSK Investigational Site | Palermo | 90127 | Italy |
| GSK Investigational Site | Roma | 00168 | Italy |
| GSK Investigational Site | Chiba | 270-1694 | Japan |
| GSK Investigational Site | Ehime | 791-0295 | Japan |
| GSK Investigational Site | Fukui | 918-8503 | Japan |
| GSK Investigational Site | Gunma | 371-8511 | Japan |
| GSK Investigational Site | Hiroshima | 730-8619 | Japan |
| GSK Investigational Site | Hiroshima | 734-8551 | Japan |
| GSK Investigational Site | Hokkaido | 006-8555 | Japan |
| GSK Investigational Site | Kagawa | 760-8557 | Japan |
| GSK Investigational Site | Kanagawa | 259-1143 | Japan |
| GSK Investigational Site | Nagano | 390-8621 | Japan |
| GSK Investigational Site | Nagasaki | 856-8562 | Japan |
| GSK Investigational Site | Nara | 634-8522 | Japan |
| GSK Investigational Site | Osaka | 545-8586 | Japan |
| GSK Investigational Site | Osaka | 591-8025 | Japan |
| GSK Investigational Site | Shizuoka | 431-3192 | Japan |
| GSK Investigational Site | Tokyo | 113-8603 | Japan |
| GSK Investigational Site | Tokyo | 162-8655 | Japan |
| GSK Investigational Site | Tokyo | 173-8606 | Japan |
| GSK Investigational Site | Tokyo | 181-8611 | Japan |
| GSK Investigational Site | Mexico City | 06700 | Mexico |
| GSK Investigational Site | Mexico City | 14080 | Mexico |
| GSK Investigational Site | Monterrey | 64020 | Mexico |
| GSK Investigational Site | Częstochowa | 42-217 | Poland |
| GSK Investigational Site | Katowice | 40-659 | Poland |
| GSK Investigational Site | Mysłowice | 41-400 | Poland |
| GSK Investigational Site | Warsaw | 03-712 | Poland |
| GSK Investigational Site | Wroclaw | 51-162 | Poland |
| GSK Investigational Site | Kemerovo | 650000 | Russia |
| GSK Investigational Site | Moscow | 119121 | Russia |
| GSK Investigational Site | Samara | 443063 | Russia |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| GSK Investigational Site | Basingstoke | RG24 9NA | United Kingdom |
| GSK Investigational Site | Glasgow | G31 2ER | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE4 5PL | United Kingdom |
| GSK Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| GSK Investigational Site | Reading Berkshire | RG1 5AN | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| GSK Investigational Site | Surrey | RH1 5RH | United Kingdom |
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002780 | Cholestasis, Intrahepatic |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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