Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
NCT ID: NCT04594694
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2019-10-02
2025-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A: BZF 200 milligrams (mg) Immediate release (IR)
Participants will receive Bezafibrate (BZF) 200 mg IR + OCA Placebo + BZF 400 mg Placebo
Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
OCA Placebo
One tablet daily for the remainder of the study
Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Treatment B: BZF 400 mg SR
Participants will receive BZF 400 mg SR + OCA Placebo + BZF 200 mg Placebo
OCA Placebo
One tablet daily for the remainder of the study
Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Treatment C: OCA 5 mg to 10 mg + BZF 200 mg IR
Participants will receive OCA 5 mg to 10 mg + BZF 200 mg IR + BZF 400 mg Placebo
Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
Treatment D: OCA 5 mg to 10 mg + BZF 400 mg SR
Participants will receive OCA 5 mg to 10 mg + BZF 400 mg SR + BZF 200 mg Placebo
Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Long-term safety extension (LTSE) phase: OCA + BZF
Participants will continue the original treatment assignment allocated during the DB Period. The OCA and BZF dose may be optimized based on safety and efficacy during the DB period.
OCA
OCA one tablet will be administered.
Bezafibrate
Bezafibrate one tablet will be administered.
Interventions
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Obeticholic acid
5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
Bezafibrate 200 MG
200 mg IR tablet of Bezafibrate once daily for the remainder of the study
OCA Placebo
One tablet daily for the remainder of the study
Bezafibrate 200 mg Placebo
One tablet daily for the remainder of the study
Bezafibrate 400 MG
400 mg SR tablet of Bezafibrate once daily for the remainder of the study
Bezafibrate 400 mg Placebo
One tablet daily for the remainder of the study
OCA
OCA one tablet will be administered.
Bezafibrate
Bezafibrate one tablet will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Intercept Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lynda Szczech
Role: STUDY_DIRECTOR
Intercept Pharmaceuticals, Inc.
Locations
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Flinders Medical Centre
Bedford Park, Perth, Australia
Royal Adelaide Hospital
Adelaide, , Australia
UZ Gasthuisberg
Leuven, , Belgium
Clinical Hospital Dubrava
Zagreb, , Croatia
Zagreb University Hospital Center
Zagreb, , Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Artroscan s.r.o., Gastroenterologicka ambulance
Ostrava, , Czechia
Research Site s.r.o.
Pilsen, , Czechia
Tartu University Hospital
Tartu, , Estonia
Hôpital Henri Mondor
Créteil, , France
Centre Hospitalier Universitaire Grenoble
Grenoble, , France
CHRU de Lille
Lille, , France
Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris
Paris, , France
CHU Paris Est - Hopital Saint Antoine
Paris, , France
Universitatsklinikum Hamburg-Eppendorf UKE
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa
Larissa, , Greece
Budai Hepatologiai Centrum (BHC)
Budapest, , Hungary
DEOEC II. sz. Belgyógyászati Klinika
Debrecen, , Hungary
Hadassah Ein-Karem Medical Center - Liver unit
Jerusalem, , Israel
Tel Aviv Surasky Medical Center
Tel Aviv, , Israel
Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
Kaunas, , Lithuania
Vlinius University
Vilnius, , Lithuania
Academisch Medisch Centrum
Amsterdam, , Netherlands
Universitetet i Oslo - Akershus Universitetssykehus (AHUS)
Loerenskog, , Norway
Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej
Warsaw, , Poland
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Fundacio Clinic Per La Recerca Biomedica
Barcelona, , Spain
Consorcio Hospital General Universitario
Valencia, , Spain
Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Institute of Cellular Medicine, Newcastle University
Newcastle upon Tyne, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.
Other Identifiers
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747-213
Identifier Type: -
Identifier Source: org_study_id
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