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RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

The purpose of this voluntary research study is to determine if an investigational drug, seladelpar, is safe and effective in treating patients with Primary Biliary Cholangitis compared to placebo (which looks like the study drug but is not active medication). This is a Phase 3, international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study when administered for up to 12 months as a daily oral capsule in patients with PBC.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04620733
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Inclusion Criteria:
PBC diagnosis with liver biopsy
UDCA stable dose 3 months
Alkaline phosphatase > 1.67
Alanine transaminase < 3Xupper level normal
platelet count > 100
Exclusion Criteria:
liver transplant
hepatitis b, hepatitis c, HIV infection
cirrhosis
cancer, 2 years
Digestive Systems & Liver Disease
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Study Locations

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Location
Hershey, PA