Pruritus
Conditions
Keywords
Primary Biliary Cholangitis (PBC), Cholestatic Pruritus, Linerixibat, Pruritus, Autoimmune Liver Disease
Brief summary
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Participants will continue receiving linerixibat while researchers monitor adverse events and other safety measures to better understand the long-term safety of treatment and provide continued access to therapy.
Interventions
DRUGLinerixibat
Linerixibat will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into an eligible linerixibat clinical study prior to LLSAT (GLIMMER or GLISTEN) * Participants must have completed the main treatment period in LLSAT * A Female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following applies: * Is a woman of non-childbearing potential (WONCBP), OR * Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method 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, etc.) * WOCBP must have a negative highly sensitive urine pregnancy test (or serum, as required by local regulations) within 7 days before the baseline visit * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive * Capable of giving signed informed consent
Exclusion criteria
* Participants who met LLSAT protocol-defined Liver Monitoring or Liver Stopping criteria and who remain off study treatment or where Liver Event is not resolved at the Final Visit in LLSAT * Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites) * Presence of confirmed hepatocellular carcinoma or biliary cancer * Current clinically significant diarrhea in the investigator's medical opinion * Any current medical condition (e.g., psychiatric disorder, senility, or dementia) which, in the investigator's opinion, may affect the participant's ability to comply with protocol-specified procedures * Current enrollment or participation in any other clinical study (except for LLSAT) involving an investigational study treatment within 8 weeks prior to the Screening Visit * Corrected QT Interval (QTc) \>480 milliseconds (msec) at screening (12-lead Electrocardiogram \[ECG\]), subject to rescreening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Up to approximately 18 months (End of study) |
| Number of Participants With AEs by Severity | Up to approximately 18 months (End of study) |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed