Last updated 6 days ago
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
180 patients around the world
Available in Argentina
Mirum Pharmaceuticals, Inc.
6Research sites
180Patients around the world
This study is for people with
Cholangitis
Primary biliary cholangitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 and anti-pruritic medication use will be allowed if meeting additional criteria.Qualified pruritus associated with PBC as assessed by Adult ItchRO.
- 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.
Sites
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Hospital El Cruce - Nestor Kirchner
Recruiting
Centro Médico Saavedra
Recruiting
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Recruiting
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Hospital de Clínicas de Porto Alegre
Recruiting
StudyVANTAGE
SponsorMirum Pharmaceuticals, Inc.
Study typeInterventional
Conditions
Primary biliary cholangitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05050136
