Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
NCT ID: NCT06365424
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
117 participants
INTERVENTIONAL
2017-04-08
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UDCA
UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
UDCA+Fenofibrate
Fenofibrate
Fenofibrate (200 mg/day)
UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
Interventions
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Fenofibrate
Fenofibrate (200 mg/day)
UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Long-term use of immunosuppressive agents
* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
18 Years
75 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Han Ying
Professor
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Ying Han
Role: primary
Other Identifiers
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KY20151230-5-1
Identifier Type: -
Identifier Source: org_study_id
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