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 Sclerosing Cholangitis (VISTAS)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Primary Sclerosing Cholangitis
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Age: Between 18 Year(s) - 120 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Have a confirmed PSC diagnosis.
You may not be eligible for this study if the following are true:
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- Pruritus associated with an etiology other than PSC.
- Evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events.
- Presumptive or diagnosed ascending cholangitis.
- Placement of a percutaneous drain or biliary stent.
- Balloon dilatation procedure of a stricture.
- 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 diseases.
- Positive for HIV antibody.
- Clinically relevant alcohol use disorder or drug abuse.
- Female participants who are pregnant or nursing.
- Known intolerance/hypersensitivity to volixibat.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.