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

Description

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.

Conditions

Primary Biliary Cholangitis, PBC

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Primary Biliary Cholangitis
Intervention / Treatment

-

Contacts and Locations

Coronado

Southern California Research Center, Coronado, California, United States, 92218

Culver City

Science 37, Inc (Remote-homebased Telemedicine), Culver City, California, United States, 90230

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Fort Myers

Covenant Metabolic Specialists, Fort Myers, Florida, United States, 33912

Gainesville

UF Hepatology Research at CTRB, Gainesville, Florida, United States, 32610

Jacksonville

UF Health Gastroenterology- Emerson, Jacksonville, Florida, United States, 32209

Kissimmee

IHS Health, Kissimmee, Florida, United States, 34741

Miami

Schiff Center for Liver Diseases, Miami, Florida, United States, 33136

New Port Richey

Advanced Research Institute, Inc, New Port Richey, Florida, United States, 34653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirum Pharmaceuticals, Inc.,

Study Record Dates

2025-12