Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Recruiting
Phase 2
Phase 3
Interventional Study
Primary Biliary Cholangitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 117 (estimated)
- Sponsor
- Xijing Hospital of Digestive Diseases · Other
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About This Trial
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Trial Locations
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Eligibility Criteria
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 le…
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