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The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have cholestatic pruritus associated with PBC who are deemed at high risk of a significant clinical event as a result of their pruritus and for whom all available pharmaceutical treatment options for cholestatic pruritus have been unsuccessful or are considered to not be appropriate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linerixibat | Drug | open label investigational product |
Inclusion Criteria:
Participants with cholestatic pruritus associated to PBC identified by their healthcare provider as being at high risk of a significant clinical event as a result of their pruritus.
Male and female >= 18 years of age.
Participants for whom all available pharmaceutical treatments for cholestatic pruritus in PBC have been unsuccessful or are considered to not be appropriate.
Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |