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Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

NCT04594694

TerminatedPhase 2

Sponsor: Intercept Pharmaceuticals

Conditions: Primary Biliary Cholangitis

Interventions: Obeticholic acid, Bezafibrate 200 MG, OCA Placebo, Bezafibrate 200 mg Placebo, Bezafibrate 400 MG

Countries: Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Greece

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Clinical complications of PBC
* History or presence of hepatic 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 other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (33)
  • Bedford Park, Perth, Australia
  • Adelaide, Australia
  • Leuven, Belgium
  • Zagreb, Croatia
  • Zagreb, Croatia
  • Hradec Králové, Czechia
  • Ostrava, Czechia
  • Pilsen, Czechia
  • Tartu, Estonia
  • Créteil, France
  • Grenoble, France
  • Lille, France
  • Paris, France
  • Paris, France
  • Hamburg, Germany
  • Hanover, Germany
  • Larissa, Greece
  • Budapest, Hungary
  • Debrecen, Hungary
  • Jerusalem, Israel
  • Tel Aviv, Israel
  • Kaunas, Lithuania
  • Vilnius, Lithuania
  • Amsterdam, Netherlands
  • Loerenskog, Norway
  • Warsaw, Poland
  • Busan, South Korea
  • Daegu, South Korea
  • Barcelona, Spain
  • Valencia, Spain
  • + 3 more on CT.gov