Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
ConditionPrimary Biliary Cholangitis
Trial statusRecruiting
Trial phasePhase 2, Phase 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 Effectiveness of Fenofibrate 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)
Participated in the PBC study with fenofibrate (NCT02823353)
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 fenofibrate discontinuation
A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
Known history of other liver diseases
For females, pregnancy or breast-feeding
Trial design
Design model
Parallel
Treatments tested in this trial
Fenofibrate
DrugFenofibrate (200 mg/day)
UDCA
DrugUrsodeoxycholic acid (13-15 mg/kg/day)
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: UDCAActive comparator 1 intervention
Group B: UDCA+FenofibrateExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Treatment emergent adverse events (TEAEs)
Time frame
Through study completion, up to 120 Months2
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Time frame
Through study completion, up to 120 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov