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Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

RecruitingPhase 3Ages 18 Years - 75 YearsAllXijing Hospital of Digestive Diseases
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In plain words

What the trial is, and whether it could suit you

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) 2. Completed in a PBC study with fenofibrate(NCT05751967) 3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose Exclusion Criteria: 1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
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What it tests

  • Fenofibrate in Combination With Ursodeoxycholic Acid
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Where

1 site
Xijing hospital
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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