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Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Study on Seladelpar's impact on liver enzyme levels in PBC patients.

Recruiting
18-75 years
All
Phase 3

We're studying a drug called seladelpar to see if it helps people with a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the body's immune system attacks the liver. We're looking for people who have tried another treatment called ursodeoxycholic acid (UDCA) and either didn't respond well or couldn't tolerate it. The main goal is to see if seladelpar can help lower a liver enzyme called alkaline phosphatase (ALP) to normal levels by week 52.

  • Duration: This study lasts for 52 weeks, which is about one year.
  • Visits: Participants will need to visit the study center regularly.
  • Eligibility: You need to have PBC and either be taking UDCA or unable to tolerate it. Also, certain health conditions or medications might make you ineligible.

Before joining, you will need to take a pregnancy test if you're a woman who can become pregnant, and everyone must agree to use birth control during the study. Make sure to talk to the study team if you have any health conditions or are taking other medications.

Study details
    Primary Biliary Cholangitis

NCT06060665

Gilead Sciences

13 April 2025

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