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Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis (PBC-Phase 2)

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ClinicalTrials.gov Identifier: NCT02943447
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Cilofexor Drug: Placebo to match Cilofexor Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Biliary Cholangitis Without Cirrhosis
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : September 4, 2019


Arm Intervention/treatment
Experimental: Cilofexor 30 mg (Blinded Study Phase)
Cilofexor 30 mg + placebo to match Cilofexor 100 mg for 12 weeks
Drug: Cilofexor
Tablet(s) administered orally once daily
Other Name: GS-9674

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

Experimental: Cilofexor 100 mg (Blinded Study Phase)
Cilofexor 100 mg + placebo to match Cilofexor 30 mg for 12 weeks
Drug: Cilofexor
Tablet(s) administered orally once daily
Other Name: GS-9674

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

Placebo Comparator: Placebo (Blinded Study Phase)
Placebo to match Cilofexor 30 mg + placebo to match Cilofexor 100 mg for 12 weeks
Drug: Placebo to match Cilofexor
Tablet(s) administered orally once daily

Experimental: Cilofexor (Open Label Extension Phase)
Following the Blinded Study Phase, eligible participants may have the option to receive Cilofexor for an additional 96 weeks.
Drug: Cilofexor
Tablet(s) administered orally once daily
Other Name: GS-9674




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  2. Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  3. Incidence of treatment-emergent laboratory abnormalities [ Time Frame: Up to 12 weeks plus 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Meets all of the following conditions

    • 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 (based on liver biopsy) 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 using direct bilirubin instead of total bilirubin.

Key Exclusion Criteria:

  • Alanine aminotransferase (ALT) > 5 x ULN
  • 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943447


  Hide Study Locations
Locations
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United States, California
Sacramento, California, United States, 95616
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Lakewood Ranch, Florida, United States, 34202
Miami, Florida, United States, 33136
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Minnesota
Saint Paul, Minnesota, United States, 55117
United States, Texas
Arlington, Texas, United States, 76012
Dallas, Texas, United States, 75204
Houston, Texas, United States, 77030
Southlake, Texas, United States, 75246
United States, Virginia
Charlottesville, Virginia, United States, 22904
Richmond, Virginia, United States, 23226
United States, Washington
Seattle, Washington, United States, 98104
Austria
Graz, Austria
Vienna, Austria
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Toronto, Ontario, Canada
Vaughan, Ontario, Canada
Canada
Vancouver, Canada
United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02943447     History of Changes
Other Study ID Numbers: GS-US-427-4024
2016-002443-42 ( EudraCT Number )
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Cholestasis