Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
NCT ID: NCT02943460
Last Updated: 2021-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2016-11-29
2020-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cilofexor 100 mg (Blinded Study Phase)
Cilofexor 100 mg + placebo to match cilofexor 30 mg for up to 12.6 weeks
Cilofexor
Tablet(s) administered orally once daily with food
Placebo to match cilofexor
Tablet(s) administered orally once daily with food
Cilofexor 30 mg (Blinded Study Phase)
Cilofexor 30 mg + placebo to match cilofexor 100 mg for up to 12.7 weeks
Cilofexor
Tablet(s) administered orally once daily with food
Placebo to match cilofexor
Tablet(s) administered orally once daily with food
Placebo (Blinded Study Phase)
Placebo to match cilofexor 30 mg + placebo to match cilofexor 100 mg for up to 12.3 weeks
Placebo to match cilofexor
Tablet(s) administered orally once daily with food
Cilofexor (Open Label Extension Phase)
Following the Blinded Study Phase, eligible participants received cilofexor for an additional up to 97.4 weeks.
Cilofexor
Tablet(s) administered orally once daily with food
Interventions
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Cilofexor
Tablet(s) administered orally once daily with food
Placebo to match cilofexor
Tablet(s) administered orally once daily with food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum alkaline phosphatase (ALP) \> 1.67 x upper limit of the normal range (ULN)
* For individuals on ursodeoxycholic acid (UDCA), the dose of UDCA must have been stable for at least 12 months prior to screening through the end of treatment. For individuals not on UDCA, no UDCA use for at least 12 months before screening through the end of treatment
* For individuals being administered biologic treatments (eg, antitumor necrosis factor (TNF) or anti-integrin monoclonal antibodies), immunosuppressants or systemic corticosteroids, the dose must have been stable at least 3 months prior to screening and anticipated to remain stable throughout the trial
* Screening FibroSURE/FibroTest® \<0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin.
Exclusion Criteria
* Total bilirubin \> 2 x ULN
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography)
* Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions. Individuals with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy;
* Ascending cholangitis within 60 days of screening
* Presence of a percutaneous drain or bile duct stent
* Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
* Cirrhosis of the liver as defined by any of the following:
* Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
* Liver stiffness \> 14.4 kilopascal (kPa) by FibroScan
* Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of \> 1 and/or a score on the Rectal Bleeding domain \> 0.
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Florida Digestive Health Specialists
Lakewood Rch, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Intermountain Medical Center - Transplant Services
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Universitätsklinik Klinik für Innere Medizin III
Vienna, , Austria
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
New Queen Elizabeth Hospital NHS Foundation Trust
Birmingham, , United Kingdom
Royal Free Hospital
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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Trauner M, Gulamhusein A, Hameed B, Caldwell S, Shiffman ML, Landis C, Eksteen B, Agarwal K, Muir A, Rushbrook S, Lu X, Xu J, Chuang JC, Billin AN, Li G, Chung C, Subramanian GM, Myers RP, Bowlus CL, Kowdley KV. The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis. Hepatology. 2019 Sep;70(3):788-801. doi: 10.1002/hep.30509. Epub 2019 Mar 10.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002442-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-428-4025
Identifier Type: -
Identifier Source: org_study_id
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