A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

Launched by MIRUM PHARMACEUTICALS, INC. · Sep 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called volixibat to see if it can help relieve itching (also known as pruritus) in patients with Primary Biliary Cholangitis (PBC), a liver disease. The main goal is to understand how effective and safe this drug is for people who experience itching due to PBC, while also looking at how it might affect the progression of the disease.

To participate in this study, you need to be at least 18 years old and have a confirmed diagnosis of PBC. You should also be able to provide consent and attend all study visits. The trial is currently recruiting participants, including both men and women. If you are experiencing itching related to PBC, this might be an opportunity for you to explore a potential new treatment option. Throughout the study, participants will be monitored closely and will receive information about the treatment process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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