Actively Recruiting
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-08-05
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety and tolerability of fenofibrate in adults with Primary Biliary Cholangitis (PBC). The study is an early phase 1, open-label trial led by Xijing Hospital of Digestive Diseases, focusing on monitoring treatment-emergent adverse events over a period of up to 120 months. The goal is to better understand how fenofibrate affects patients with this liver condition over time. Participants will receive fenofibrate at a dose of 200 mg as the study treatment. The trial does not involve a placebo or comparison group and is conducted without blinding. The treatment period spans up to 10 years, allowing for long-term observation of fenofibrate's effects on PBC. Throughout the study, participants will be regularly monitored for any adverse events, including treatment-related side effects. Researchers will assess key outcomes such as normalization of alkaline phosphatase (ALP) levels, occurrence of death, and the need for liver transplantation. The total duration for each participant may be up to 120 months, with ongoing safety and efficacy assessments during this time.
CONDITIONS
Brief Title
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have given written informed consent (signed and dated)
- Completed in a PBC study with fenofibrate (NCT06591455)
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 120 months
Participants receive Fenofibrate 200mg to evaluate safety and tolerability in Primary Biliary Cholangitis.
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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