The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Tablets administered orally once daily
Arizona Liver Health
Chandler, Arizona, United States
California Liver Research Institute
Pasadena, California, United States
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) were either defined any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to 12 weeks plus 30 days
Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events (SAEs)
A treatment emergent SAE was defined as an event that, at any dose, resulted in the following: death ; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; a medically important event or reaction: such events may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes constituting SAEs.
Time frame: First dose date up to 12 weeks plus 30 days
Percentage of Participants Who Experienced Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening.
Time frame: First dose date up to 12 weeks plus 30 days
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University of California San Francisco, Liver Clinic
San Francisco, California, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Minnesota Gastroenterology, PA
Maplewood, Minnesota, United States
Northwell Health Center for Liver Diseases and Transplantation
Manhasset, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
...and 6 more locations