Resumen

Este es un estudio de seguridad a largo plazo, abierto, sin comparador, global, multicéntrico, para evaluar la seguridad y tolerabilidad de linerixibat en participantes con prurito colestásico en colangitis biliar primaria (CBP) que participaron en un ensayo clínico previo con linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (grupo 1) o 212620 GLISTEN [NCT00210418]) (grupo 2). Todos los participantes recibirán linerixibat abierto durante la duración del estudio. Se espera que la duración del estudio dure hasta la finalización del estudio o hasta que linerixibat pueda estar legalmente disponible para los participantes. Sin embargo, la duración total de la participación en el estudio variará según el participante dependiendo del momento de entrada en relación con la finalización del estudio en su respectivo país.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
Capable of giving signed informed consent.

Criterios de exclusión

Screening total bilirubin \>2x upper limit of normal (ULN).
Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>6x ULN.
Screening estimated glomerular filtration rate (eGFR) \<30 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B \[HBV\], viral Hepatitis C \[HCV\]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
Current clinically significant diarrhea in the Investigator's medical opinion.
Current symptomatic cholelithiasis or cholecystitis.
Current diagnosis or previous diagnosis of colorectal cancer.
Any current malignancies (including hematologic and solid malignancies).
History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
QT interval corrected (QTc) \>480 millisecond (msec) at screening (12-lead ECG)
Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Santa Fe, Argentina

Estudio de seguridad y tolerabilidad a largo plazo de linerixibat para el tratamiento del prurito colestásico en participantes con colangitis biliar primaria

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Linerixibat

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores