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 Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.
Time frame: Baseline through to Week 28
Proportion of participants with itch response using the Adult ItchRO
Time frame: Baseline through to Week 28
The incidence of adverse events
Time frame: Baseline through to Week 28
Changes in serum bile acid levels
Time frame: Baseline through to Week 28
Changes in alkaline phosphatase
Time frame: Baseline through to Week 28
Changes in total bilirubin levels
Time frame: Baseline through to Week 28
Change in Primary Sclerosing Cholangitis-Specific Patient-Reported Outcome
Time frame: Baseline through to Week 28
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire
The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always.
Time frame: Baseline through to Week 28
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire
The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good.
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Southern California Research Center
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Research Institute
Lakewood Rch, Florida, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 93 more locations
Time frame: Baseline through to Week 28