Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
NCT ID: NCT02943447
Last Updated: 2020-09-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
71 participants
INTERVENTIONAL
2016-12-01
2019-09-04
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 30 mg (Blinded Study Phase)
Cilofexor 30 mg + placebo to match cilofexor 100 mg for 12 weeks.
Cilofexor
Tablet(s) administered orally once daily, with food
Placebo to match cilofexor
Tablet(s) administered orally once daily, with food
Cilofexor 100 mg (Blinded Study Phase)
Cilofexor 100 mg + placebo to match cilofexor 30 mg for 12 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 12 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 may have the option to receive open-label cilofexor 100 mg for an additional 96 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
* Definite or probable PBC as defined by at least 2 of the 3 following criteria:
* Serum alkaline phosphatase (ALP) \> the upper limit of normal (ULN)
* Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on immunofluorescence)
* Liver histological findings consistent with PBC including nonsuppurative, destructive cholangitis affecting mainly the interlobular bile and septal bile ducts
* Serum ALP \> 1.67 x ULN and/or total bilirubin \>ULN but ≤ 2 x ULN
* Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or intolerant of UDCA with no UDCA use for at least 12 months before screening
* 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
* Other causes of liver disease including viral, metabolic, alcoholic, and other autoimmune conditions. Participants 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.
* 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)
* History of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
* Liver stiffness \> 16.9 kPa by FibroScan®
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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Sacramento, California, United States
Aurora, Colorado, United States
Lakewood Rch, Florida, United States
Miami, Florida, United States
Marietta, Georgia, United States
Saint Paul, Minnesota, United States
Arlington, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Newport News, Virginia, United States
Seattle, Washington, United States
Graz, Styria, Austria
Vienna, Vienna, Austria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Vaughan, Ontario, Canada
Birmingham, England, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
Norwich, England, United Kingdom
Countries
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References
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Kowdley KV, Minuk GY, Pagadala MR, Gulamhusein A, Swain MG, Neff GW, et al. The Nonsteroidal Farnesoid X Receptor (FXR) Agonist Cilofexor Improves Liver Biochemistry in Patients with Primary Biliary Cholangitis (PBC): A Phase 2, Randomized, Placebo-Controlled Trial [Abstract 45]. Hepatology AASLD Abstracts 2019;70 (Suppl 1):31A-2A.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002443-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-427-4024
Identifier Type: -
Identifier Source: org_study_id
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