Last updated: 02/25/2025 05:20:14
Linerixibat compassionate use for cholestatic pruritus adult patients with Primary Biliary Cholangitis (PBC)
GSK study ID
217327
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Available
Available
Trial overview
Official title: Linerixibat compassionate use for cholestatic pruritus in adult patients with Primary Biliary Cholangitis
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
5
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pruritus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Expanded Access
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- 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.
- Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy).
- Use of obeticholic acid or other IBAT inhibitor.
Inclusion and exclusion criteria
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: a. Is not a woman of childbearing potential (WOCBP) OR b. Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat.
Exclusion criteria:
- Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy).
- Use of obeticholic acid or other IBAT inhibitor.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Not applicable
Results overview
Not applicable
Recruitment status
Available
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable
Additional information about the trial
Additional information
Not applicable
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