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Pacific Study for Cholestatic Pruritis

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Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

  • Sex at Birth: Any
  • Age: Child (Birth - 17), Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase II
  • Conditions Being Studied: Liver, Primary Biliary Cholangitis

Study Purpose

The primary purpose of this study to assess the effectiveness of EP547 compared to placebo (a substance that looks like EP547 but has no active drug) in relieving symptoms in patients with itch associated with cholestatic liver disease. Other purposes of the study are to find out the safety and tolerability (the degree to which side effects affect a participant’s willingness to continue taking study drug) of the study drug EP547 in patients with itch associated with cholestatic liver disease and to determine the amount of EP547 in the blood after dosing.

Who Can Participate

Age: 15-80

Principal Investigator
Seth Sclair MD
Department/Division
Medicine (Gastroenterology)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: STUDY20221252
  • StudyID: 2021-0725
  • ClinicalTrials.gov: NCT05525520
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