J-LINX: Japan LINerixibat eXtension Study
Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC
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.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
Studera Kontakt Backup
- Namn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-post: GSKClinicalSupportHD@gsk.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Linerixibat
Participants with cholestatic pruritus associated with primary biliary cholangitis (PBC) who completed the LLSAT study will receive linerixibat. |
Linerixibat will be administered. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Tidsram: Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
|
Number of Participants With AEs by Severity
Tidsram: Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Matsmältningssystemets sjukdomar
- Hudmanifestationer
- Gallvägssjukdomar
- Leversjukdomar
- Hudsjukdomar
- Gallgångssjukdomar
- Fibros
- Kolestas, intrahepatisk
- Kolestas
- Levercirros
- Patologiska tillstånd, tecken och symtom
- Hud- och bindvävssjukdomar
- Tecken och symtom
- Levercirros, gallvägar
- Klåda
Andra studie-ID-nummer
- 309859
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Tidsram för IPD-delning
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Kriterier för IPD Sharing Access
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
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