Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intercept Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A definite or probable diagnosis of PBC
Qualifying ALP and/or bilirubin liver biochemistry values
Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
You may not be if
History or presence of other concomitant liver diseases
Presence of clinical complications of PBC
History or presence of decompensating events
Current or history of gallbladder disease
If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.
Clareo Health | Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
