A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients Wi… (NCT04663308) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
United States182 participantsStarted 2020-12-18
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period.
✓. Subjects aged ≥12 years for eligible regions; otherwise ≥18 years
✓. Confirmed diagnosis of large duct or small duct PSC based on American Association for the Study of Liver Disease (AASLD) guidelines.
✓. Pruritus associated with PSC as assessed by Adult ItchRO.
✓. Ursodeoxycholic acid (UDCA) and anti-pruritic medication use will be allowed if meeting additional criteria.
✓. Concomitant Inflammatory Bowel Disease (IBD) is allowed if meeting additional criteria.
Exclusion criteria
✕. Pruritus associated with an etiology other than PSC
✕. Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events
✕. History of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation
✕. Evidence, history, or suspicion of other liver disease; PSC patients with AIH are not excluded.
✕. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
What they're measuring
1
Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire