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Clinical Studies
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A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC)
Rochester, Minn.
Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
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A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating The Safety And Efficacy Of LB P8 In Patients With Primary Sclerosing Cholangitis (PSC)
Rochester, Minn.,
Jacksonville, Fla.
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
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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 Biliary Cholangitis (VANTAGE) (VANTAGE)
Rochester, Minn.
The purpose of this study is investigating the safety and effectiveness of Volixibat in the treatment of cholestatic pruritis.
Closed for Enrollment
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A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (EPICS-III)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to to evaluate the effectiveness and safety of Saroglitazar Magnesium’s optimal dose (1 or 2 mg) and placebo in subjects with primary biliary cholangitis (PBC).
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis (PSC-Phase 3)
Rochester, Minn.
The primary purpose of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
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A Prospective, Randomized, Multi-centered, Placebo-controlled, Clinical Trial of Oral Vancomycin in Adults with Primary Sclerosing Cholangitis
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to to assess the effects of different Oral Vancomycin (OV) doses on the clinical and biochemical course in adult patients with Primary Sclerosing Cholangitis (PSC).
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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)
Rochester, Minn.
The purpose of this study is to learn more about 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.
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Investigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC) (PSC)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period on the clinical course and progression of primary sclerosing cholangitis.
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