NCT06365424RecruitingPhase 2
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases1 site in 1 country117 target enrollmentStarted: April 8, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Percentage of patients with biochemical response
Study Overview
Brief Summary
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
UDCA+Fenofibrate
Experimental
Intervention: Fenofibrate (Drug)
UDCA+Fenofibrate
Experimental
Intervention: UDCA (Drug)
UDCA
Active Comparator
Intervention: UDCA (Drug)
Outcomes
Primary Outcomes
Percentage of patients with biochemical response
Time Frame: Through study completion, up to 120 Months
The normalisation of Alkaline Phosphatase
Treatment emergent adverse events (TEAEs)
Time Frame: Through study completion, up to 120 Months
Secondary Outcomes
No secondary outcomes reported
Investigators
Han Ying
Professor
Xijing Hospital of Digestive Diseases
Study Sites (1)
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