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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02943460
Other study ID # GS-US-428-4025
Secondary ID 2016-002442-23
Status Completed
Phase Phase 2
First received
Last updated
Start date November 29, 2016
Est. completion date May 18, 2020

Study information

Verified date May 2021
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date May 18, 2020
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: - Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months - 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. Key Exclusion Criteria: - Alanine aminotransferase (ALT) > 10 x ULN - 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Intervention

Drug:
Cilofexor
Tablet(s) administered orally once daily with food
Placebo to match cilofexor
Tablet(s) administered orally once daily with food

Locations

Country Name City State
Austria Universitätsklinik Klinik für Innere Medizin III Vienna
Canada University of Calgary Liver Unit (Heritage Medical Research Clinic) Calgary Alberta
Canada Toronto Liver Centre Toronto Ontario
United Kingdom New Queen Elizabeth Hospital NHS Foundation Trust Birmingham
United Kingdom King's College Hospital NHS Foundation Trust London
United Kingdom Royal Free Hospital London
United Kingdom Norfolk and Norwich University Hospital Norwich
United States University of Colorado Denver Aurora Colorado
United States University of Virginia Charlottesville Virginia
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Indiana University Health University Hospital Indianapolis Indiana
United States Florida Digestive Health Specialists Lakewood Ranch Florida
United States Schiff Center for Liver Diseases/University of Miami Miami Florida
United States Intermountain Medical Center - Transplant Services Murray Utah
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 University of California, Davis Medical Center Sacramento California
United States Minnesota Gastroenterology, P.A. Saint Paul Minnesota
United States University of California San Francisco San Francisco California
United States Swedish Organ Transplant and Liver Center Seattle Washington
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Austria,  Canada,  United Kingdom, 

References & Publications (1)

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 Agoni — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase Treatment-emergent adverse events occurring during the Blinded Phase were defined as 1 or both of the following: 1) Any adverse events (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 in the Blinded Phase (and before the first dosing date in the Open Label Extension (OLE) Phase), or 2) Any AEs leading to premature discontinuation of study drug in the Blinded Phase. First dose date up to last dose date plus 30 days (Up to 17 weeks)
Primary Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase A serious adverse event was defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction. First dose date up to last dose date plus 30 days (Up to 17 weeks)
Primary Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase Treatment-emergent laboratory abnormalities occurring during the Blinded Phase were 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 in the Blinded Phase plus 30 days (and prior to or on the first dose date of the OLE phase). The Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 was used for assigning toxicity grades (0 to 4, with higher grades indicating more severity). First dose date up to last dose date plus 30 days (Up to 17 weeks)
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