Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
Recruiting
Phase 2
Phase 3
Interventional Study
Primary Biliary Cholangitis
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
- 104 (estimated)
- Sponsor
- Xijing Hospital of Digestive Diseases · Other
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About This Trial
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Must have provided written informed consent
* Age 18-75 years;
* BMI 17-28 kg/m2
* Male or female with a diagnosis of PBC, by at least two of the following criteria:
1. History of AP above ULN for at least six months;
2. Positive AMA titers (\>1/40 on immunofluorescence o…
Contacts