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A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intoler

Clinical Trial Details

The purpose of this research study is to determine if Seladelpar is effective at normalizing disease markers in subjects with primary biliary cholangitis (PBC) who are currently on ursodeoxycholic acid (UDCA) treatment or intolerant to UDCA. 

PBC is a chronic disease of the liver resulting from progressive destruction of bile ducts in the liver. Bile is a substance produced by the liver to facilitate digestion. With PBC, the bile ducts develop inflammation and causes liver damage, which may eventually lead to cirrhosis (liver scarring). Individuals will be asked to be participants in this research study because they have been diagnosed with PBC and are currently on UDCA or intolerant to UDCA.

Seladelpar is an investigational drug. Investigational means that the drug has not been approved by regulatory authorities such as the United States Food and Drug Administration (FDA). 
      
Participants will receive 10 mg tablets of Seladelpar.

Total study participation in this study will last for up to 58 weeks and participants will be compensated for their time.

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with Primary Biliary Cholangitis (PBC) and have intolerance to UDCA

 Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
646-962-5483
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026580

Sponsor:

CB8025-32251

Status

Open to Enrollment

Age Group

Adult

Sponsor