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NCT06488911TerminatedPhase 3

To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

Source: ClinicalTrials.gov · Last updated 8 Jun 2026

Reason given: Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.

Brief summary (registry, in English)

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
62 (actual)
First submitted
28 Jun 2024
Start date
1 Jul 2024
Primary completion date
21 Oct 2025
Lead sponsor
Intercept Pharmaceuticals
NCT number
NCT06488911

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History or presence of other concomitant liver diseases

Other illness

  • Current or history of gallbladder disease

Lab values

  • If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Clinical complications of PBC
  • History or presence of hepatic decompensating events

Who the study is looking for

  • All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
DIM Clinica PrivadaBuenos AiresArgentinaUnknown status
Hospital Universitario AustralBuenos AiresArgentinaUnknown status
Hospital Italiano de Buenos AiresBuenos AiresArgentinaUnknown status
Hospital Italiano de La PlataBuenos AiresArgentinaUnknown status
Hospital Provincial del CentenarioSanta FeArgentinaUnknown status
Royal Adelaide HospitalAdelaideAustraliaUnknown status
Flinders Medical CentreBedford ParkAustraliaUnknown status
UZ LeuvenLeuvenBelgiumUnknown status
University of Alberta Division of Gastroenterology Zeidler Ledcor CentreEdmontonCanadaUnknown status
Pacific Gastroenterology Associates GI Research InstituteVancouverCanadaUnknown status
Hepato-Gastroenterologie HK, s.r.o.Hradec KrálovéCzechiaUnknown status
Artroscan s.r.o. GastroenterologickaOstravaCzechiaUnknown status
Research Site SROPilsenCzechiaUnknown status
Medizinische Hochschule HannoverHanoverGermanyUnknown status
Tartu University HospitalTartuEstoniaUnknown status
Hospital ClinicUniversity of BarcelonaBarcelonaSpainUnknown status
Consorcio Hospital General UniversitarioValenciaSpainUnknown status
Hopital Henri MondorCréteilFranceUnknown status
CHRU de LilleLilleFranceUnknown status
CHU Paris Est - Hopital Saint AntoineParisFranceUnknown status
Hôpital de la Pitié-SalpêtrièreParisFranceUnknown status
Hull University Teaching Hospitals NHS TrustHullUnited KingdomUnknown status
Institute of Cellular Medicine Newcastle UniversityNewcastle upon TyneUnited KingdomUnknown status
John Radcliffe HospitalOxfordUnited KingdomUnknown status
University Hospital of LarissaLarissaGreeceUnknown status
Universityl Hospital DubravaZagrebCroatiaUnknown status
DEOEC II. sz. Belgygyszati KlinikaDebrecenHungaryUnknown status
Hadassah Ein-Karem Medical Center - Liver unitJerusalemIsraelUnknown status
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola MalpighiBolognaItalyUnknown status
Kyungpook National University HospitalDaeguSouth KoreaUnknown status
Seoul National University Bundang HospitalSeongnam-siSouth KoreaUnknown status
University Hopital Santaros klinikosVilniusLithuaniaUnknown status
Academisch Medisch CentrumAmsterdamNetherlandsUnknown status
Akershus University HospitalLørenskogNorwayUnknown status
Hacettepe University, Faculty of Medicine, Adult Hospital GastroenterologyAnkaraTürkiyeUnknown status
Ege University, Faculty of Medicine, GastroenterologyBornovaTürkiyeUnknown status
Istanbul University, Capa Faculty of Medicine, GastroenterologyIstanbulTürkiyeUnknown status
Harran University Hospital, GastroenterologySanliurfaTürkiyeUnknown status
Piedmont Atlanta HospitalAtlantaUnited StatesUnknown status
University of Alabama at BirminghamBirminghamUnited StatesUnknown status
Beth Israel Deaconess Medical CenterBostonUnited StatesUnknown status
University Hospitals Cleveland Medical Center*ClevelandUnited StatesUnknown status
Southern California Research CenterCoronadoUnited StatesUnknown status
The Liver Institute at Methodist Dallas Medical CenterDallasUnited StatesUnknown status
Gastro OneGermantownUnited StatesUnknown status
Houston Methodist HospitalHoustonUnited StatesUnknown status
East Tennessee Research InstituteJohnson CityUnited StatesUnknown status
Ochsner Clinic FoundationNew OrleansUnited StatesUnknown status
NYU Langone HealthNew YorkUnited StatesUnknown status
American Research CorporationSan AntonioUnited StatesUnknown status
Tampa General Medical GroupTampaUnited StatesUnknown status

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