Clinical trial NCT06488911: To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Primary Biliary Cholangitis
Keywords: Primary Biliary Cholangitis
Obeticholic Acid
Bezafibrate
Ursodeoxycholic acid
Lead sponsor: Intercept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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).

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of participants reporting adverse events (AE) and serious adverse event (SAE)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score
timeFrame: Up to 60 months
measure: Number of participants reporting all-cause mortality
timeFrame: Up to 60 months
measure: Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant
timeFrame: Up to 60 months
measure: Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation
timeFrame: Up to 60 months
measure: Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Miami
country: United States
facility: University of Miami/Schiff Center for Liver Diseases
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Raleigh
country: United States
facility: Carolina's GI Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute
state: Tennessee
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Buenos Aires
country: Argentina
facility: DIM Clinica Privada
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
city: Santa Fe
country: Argentina
facility: Hospital Provincial del Centenario
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Leuven
country: Belgium
facility: UZ Leuven
city: Edmonton
country: Canada
facility: University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates GI Research Institute
state: British Columbia
city: Zagreb
country: Croatia
facility: Universityl Hospital Dubrava
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Ostrava
country: Czechia
facility: Artroscan s.r.o. Gastroenterologicka
city: Plzen
country: Czechia
facility: Research Site SRO
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lille
country: France
facility: CHRU de Lille
city: Paris
country: France
facility: CHU Paris Est - Hopital Saint Antoine
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Debrecen
country: Hungary
facility: DEOEC II. sz. Belgygyszati Klinika
city: Jerusalem
country: Israel
facility: Hadassah Ein-Karem Medical Center - Liver unit
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Vilnius
country: Lithuania
facility: University Hopital Santaros klinikos
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Barcelona
country: Spain
facility: Hospital ClinicUniversity of Barcelona
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
city: Bornova
country: Turkey
facility: Ege University, Faculty of Medicine, Gastroenterology
city: Istanbul
country: Turkey
facility: Istanbul University, Capa Faculty of Medicine, Gastroenterology
city: Şanlıurfa
country: Turkey
facility: Harran University Hospital, Gastroenterology
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Institute of Cellular Medicine Newcastle University
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Intercept Pharmaceuticals Inc.
name: Lynda Szczech, PhD
role: STUDY_DIRECTOR
References: