Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mirum Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis