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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Must have given written informed consent (signed and dated)
• Completed in a PBC study with fenofibrate(NCT05751967)
• 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
Locations
Other Locations
China
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Yansheng Liu
liuyansheng506@163.com
862984771539
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2035-12
Participants
Target number of participants: 150
Treatments
Experimental: fenofibrate
Experimental: Fenofibrate 200 mg Capsules
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital of Digestive Diseases