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About
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)
Enrollment
Sex
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Volunteers
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:
Incomplete response to UDCA defined by 1 x ULN< ALP <= 1.67 x ULN
Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
Exclusion criteria
Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
Primary purpose
Allocation
Interventional model
Masking
184 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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