Review the following criteria to determine if your patient qualifies for the VISTAS Study.
Ages Eligible for Study: 12 Years and older
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
- Exceeding pre-defined biochemical values for alanine aminotransferase/ aspartate aminotransferase (ALT/AST), estimated glomerular filtration rate (eGFR), serum creatinine (sCr), platelet count, international normalized ratio (INR) and total bilirubin.
- History of liver transplantation.
