Fenofibrate in Primary Biliary Cholangitis: a Real World Study
ConditionPrimary Biliary Cholangitis (PBC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital of Digestive Diseases
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have given written informed consent (signed and dated)
Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
ALP> 1*ULN
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
Disqualifiers
Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Trial design
Design model
Single group
Treatments tested in this trial
Fenofibrate
DrugFenofibrate 200mg
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: fenofibrateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment emergent adverse events (TEAEs)
Time frame
Through study completion, up to 120 MonthsSecondary outcomes
1
Death
Occurrence of overall death
Time frame
120 months2
Liver transplantation
Time frame
120 months3
Normalization of ALP
Proportion of subjects with normalization of ALP
Time frame
120 monthsSponsors and contacts
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Source ClinicalTrials.gov