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IDEAL: 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 Intolerance to Ursodeoxycholic Acid (UDCA)

IDEAL: Studying Seladelpar's effects on liver enzyme levels in PBC patients.

Recruiting
18-75 years
All
Phase 3

Primary Biliary Cholangitis (PBC) is a liver disease where the bile ducts become damaged. This study looks at how well a drug called Seladelpar works for people with PBC who haven't responded well to another treatment, Ursodeoxycholic Acid (UDCA). Alkaline Phosphatase (ALP) is an enzyme in the liver that is measured in this study. It helps in determining how well the liver is functioning.

To join this study, you must be 18 to 75 years old and have PBC. You shouldn't have used Seladelpar before or have other serious liver conditions. Both men and women must use reliable birth control during the study.

  • The study is for people who have tried UDCA for at least a year or can't take it.
  • It involves taking a new medication, Seladelpar.
  • Participants must follow birth control guidelines and meet specific health criteria.

It's important to discuss with your doctor if you think you qualify and want to participate. They can help decide if this study is right for you.

Study details
    Primary Biliary Cholangitis

NCT06060665

Gilead Sciences

2 February 2025

Step 1 Get in touch with the nearest study center
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