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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: US GSK Clinical Trials Call Center
- Numéro de téléphone: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Sauvegarde des contacts de l'étude
- Nom: EU GSK Clinical Trials Call Center
- Numéro de téléphone: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Linerixibat
Participants with cholestatic pruritus associated with primary biliary cholangitis (PBC) who completed the LLSAT study will receive linerixibat. |
Linerixibat will be administered. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Délai: Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
|
Number of Participants With AEs by Severity
Délai: Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système digestif
- Manifestations cutanées
- Maladies des voies biliaires
- Maladies du foie
- Maladies de la peau
- Maladies des voies biliaires
- Fibrose
- Cholestase intrahépatique
- Cholestase
- La cirrhose du foie
- Conditions pathologiques, signes et symptômes
- Maladies de la peau et du tissu conjonctif
- Signes et symptômes
- Cirrhose du foie, biliaire
- Prurit
Autres numéros d'identification d'étude
- 309859
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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