To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Drug: FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Registration Number
- NCT06488911
- Lead Sponsor
- Intercept Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 133
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OCA 5 mg + BZF 400 mg SR FDC tablet (OCA 5 mg + BZF 400 mg SR) Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.
- Primary Outcome Measures
Name Time Method Number of participants reporting adverse events (AE) and serious adverse event (SAE) Up to 60 months
- Secondary Outcome Measures
Name Time Method Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score Up to 60 months The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10-centimeter (cm) line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation Up to 60 months Number of participants reporting all-cause mortality Up to 60 months Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant Up to 60 months Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score โฅ15 Up to 60 months MELD is a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores 10-19=6.0% mortality; Score 9 or less=1.9% mortality. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status.
Trial Locations
- Locations (53)
Hopital de la Pitie Salpetriere
๐ซ๐ทParis, France
Medizinische Hochschule Hannover
๐ฉ๐ชHanover, Germany
University Hospital of Larissa
๐ฌ๐ทLarissa, Greece
DEOEC II. sz. Belgygyszati Klinika
๐ญ๐บDebrecen, Hungary
Hadassah Ein-Karem Medical Center - Liver unit
๐ฎ๐ฑJerusalem, Israel
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
๐ฎ๐นBologna, Italy
Hospital ClinicUniversity of Barcelona
๐ช๐ธBarcelona, Spain
Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology
๐น๐ทAnkara, Turkey
Harran University Hospital, Gastroenterology
๐น๐ทลanlฤฑurfa, Turkey
CHU Paris Est - Hopital Saint Antoine
๐ซ๐ทParis, France
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Southern California Research Center
๐บ๐ธCoronado, California, United States
University of Miami/Schiff Center for Liver Diseases
๐บ๐ธMiami, Florida, United States
Tampa General Medical Group
๐บ๐ธTampa, Florida, United States
Piedmont Atlanta Hospital
๐บ๐ธAtlanta, Georgia, United States
Ochsner Clinic Foundation
๐บ๐ธNew Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
NYU Langone Health
๐บ๐ธNew York, New York, United States
Carolina's GI Research, LLC
๐บ๐ธRaleigh, North Carolina, United States
University Hospitals Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Gastro One
๐บ๐ธGermantown, Tennessee, United States
East Tennessee Research Institute
๐บ๐ธJohnson City, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
๐บ๐ธDallas, Texas, United States
American Research Corporation
๐บ๐ธSan Antonio, Texas, United States
DIM Clinica Privada
๐ฆ๐ทBuenos Aires, Argentina
Hospital Italiano de Buenos Aires
๐ฆ๐ทBuenos Aires, Argentina
Hospital Italiano de La Plata
๐ฆ๐ทBuenos Aires, Argentina
Hospital Universitario Austral
๐ฆ๐ทBuenos Aires, Argentina
Hospital Provincial del Centenario
๐ฆ๐ทSanta Fe, Argentina
Houston Methodist Hospital
๐บ๐ธHouston, Texas, United States
Royal Adelaide Hospital
๐ฆ๐บAdelaide, Australia
Flinders Medical Centre
๐ฆ๐บBedford Park, Australia
UZ Leuven
๐ง๐ชLeuven, Belgium
University of Alberta Division of Gastroenterology Zeidler Ledcor Centre
๐จ๐ฆEdmonton, Alberta, Canada
Pacific Gastroenterology Associates GI Research Institute
๐จ๐ฆVancouver, British Columbia, Canada
Universityl Hospital Dubrava
๐ญ๐ทZagreb, Croatia
Hepato-Gastroenterologie HK, s.r.o.
๐จ๐ฟHradec Krรกlovรฉ, Czechia
Artroscan s.r.o. Gastroenterologicka
๐จ๐ฟOstrava, Czechia
Research Site SRO
๐จ๐ฟPlzen, Czechia
Tartu University Hospital
๐ช๐ชTartu, Estonia
Hopital Henri Mondor
๐ซ๐ทCrรฉteil, France
CHRU de Lille
๐ซ๐ทLille, France
Kyungpook National University Hospital
๐ฐ๐ทDaegu, Korea, Republic of
Seoul National University Bundang Hospital
๐ฐ๐ทSeongnam-si, Korea, Republic of
University Hopital Santaros klinikos
๐ฑ๐นVilnius, Lithuania
Academisch Medisch Centrum
๐ณ๐ฑAmsterdam, Netherlands
Akershus University Hospital
๐ณ๐ดLรธrenskog, Norway
Consorcio Hospital General Universitario
๐ช๐ธValencia, Spain
John Radcliffe Hospital
๐ฌ๐งOxford, United Kingdom
Ege University, Faculty of Medicine, Gastroenterology
๐น๐ทBornova, Turkey
Istanbul University, Capa Faculty of Medicine, Gastroenterology
๐น๐ทIstanbul, Turkey
Institute of Cellular Medicine Newcastle University
๐ฌ๐งNewcastle Upon Tyne, United Kingdom
Hull University Teaching Hospitals NHS Trust
๐ฌ๐งHull, United Kingdom