To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
Launched by INTERCEPT PHARMACEUTICALS · Jun 28, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Intercept Pharmaceuticals
Intercept Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative therapies for liver diseases. With a commitment to transforming patient outcomes, Intercept leverages its expertise in bile acid pharmacology to create targeted treatments that address unmet medical needs. The company is dedicated to advancing scientific research and clinical development in areas such as non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC), striving to deliver safe and effective solutions that improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
New Orleans, Louisiana, United States
Houston, Texas, United States
Birmingham, Alabama, United States
Buenos Aires, , Argentina
Tampa, Florida, United States
Atlanta, Georgia, United States
Leuven, , Belgium
Adelaide, , Australia
Leuven, , Belgium
Seongnam Si, , Korea, Republic Of
Buenos Aires, , Argentina
Ankara, , Turkey
Cleveland, Ohio, United States
Bedford Park, , Australia
Daegu, , Korea, Republic Of
Dallas, Texas, United States
Créteil, , France
Larissa, , Greece
Germantown, Tennessee, United States
Coronado, California, United States
New York, New York, United States
Lørenskog, , Norway
Lille, , France
Tampa, Florida, United States
San Antonio, Texas, United States
Hanover, , Germany
Paris, , France
Valencia, , Spain
Buenos Aires, , Argentina
Santa Fe, , Argentina
Miami, Florida, United States
Johnson City, Tennessee, United States
Jerusalem, , Israel
Hradec Králové, , Czechia
Buenos Aires, , Argentina
Oxford, , United Kingdom
Bologna, , Italy
Raleigh, North Carolina, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Zagreb, , Croatia
Ostrava, , Czechia
Plzen, , Czechia
Tartu, , Estonia
Paris, , France
Debrecen, , Hungary
Vilnius, , Lithuania
Amsterdam, , Netherlands
Barcelona, , Spain
Ankara, , Turkey
Bornova, , Turkey
Istanbul, , Turkey
şanlıurfa, , Turkey
Hull, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Saliurfa, Southeastern Anatolia, Turkey
Patients applied
Trial Officials
Lynda Szczech, PhD
Study Director
Intercept Pharmaceuticals Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported