Study Details
Mirum VISTAS
(IRB#: IRB_00137626)
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 PSC. Volixibat is an experimental treatment, meaning that it has not yet been approved by the US Food and Drug Administration or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels that are believed to lead to the itching in patients with PSC. There are no other medicines approved to treat itching in patients with PSC. This is the first time volixibat will be used in patients with PSC.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Have a confirmed PSC diagnosis a. Large duct PSC: diagnosis confirmed by prior abnormal cholangiography in the absence of alternative etiologies. b. Small duct PSC: diagnosis confirmed by prior consistent liver biochemistry changes and consistent liver histology, as well as evidence of an established diagnosis of concomitant IBD.
- For participants with concomitant IBD: a. Colonoscopy (if participant has a colon) or other appropriate endoscopic procedure performed within 12 to 18 months of Screening Visit 1 confirming no dysplasia or colorectal cancer b. Participants with UC must either be in remission or have mild disease. Remission is defined as a partial Mayo IBD score of <2 with no individual subscore exceeding 1 Mild disease is defined as a partial Mayo IBD score 24 with no individual subscore exceeding 2 points at screening through Day 1
Exclusion Criteria
- Pruritus associated with an etiology other than PSC
- Presumptive or diagnosed ascending cholangitis within 12 weeks of screening through Day 1
- Placement of a percutaneous drain or biliary stent within 12 weeks of screening through Day 1
Will I be paid for my time?
Yes
IRB#: IRB_00137626
PI: Juan Gallegos-Orozco
Department: GASTROENTEROLOGY
Approval Date: 2021-09-15 06:00:00
Specialties: Gastroenterology