A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05050136RENIS: IS004801Tipo: INTERVENTIONALInicio: 22 de sept de 2021Fin estimado: 1 de jul de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study
Male or female, age ≥18 years at the screening visit
Confirmed diagnosis of PBC in line with the AASLD guidelines
UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria
Qualified pruritus associated with PBC as assessed by Adult ItchRO

Criterios de exclusión

Pruritus associated with an etiology other than PBC
Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events
Current symptomatic cholelithiasis or inflammatory gallbladder disease
History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded
History of Liver transplantation

Intervenciones

drug

Volixibat

Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.

drug

Placebo

Capsules matched to study drug without the active pharmaceutical ingredient

Ubicaciones

Hospital de Alta Complejidad En Red El Cruce

San Juan Bautista, Buenos Aires, Argentina

Mariana Ambrosis · mariambrosis@gmail.com · 221- 616-5547

RECRUITING

Hospital Provincial Del Centenario

Rosario, Santa Fe Province, Argentina

Gabriela Juaristi · gabriela.juaristi@hepagastro.org.ar · +54 9 3416 28-5257

RECRUITING

Glenny Corp S.A

CABA, Argentina

Maria Belen Umina · umina.belen@centromedicosaavedra.com.ar · 54 911 3086-4247

RECRUITING

Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

Santa Fe, Argentina

Guillermina Safón Leguizamón · guillerminasafonmit@gmail.com · +54 9342 545 4219

RECRUITING

Patrocinadores

PrincipalMirum Pharmaceuticals, Inc.

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