Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02943447
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE October 24, 2016
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date July 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  • Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
  • Incidence of treatment-emergent laboratory abnormalities [ Time Frame: Up to 12 weeks plus 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02943447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
Official Title  ICMJE 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
Brief Summary The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Biliary Cholangitis
Intervention  ICMJE
  • Drug: Cilofexor
    Tablet(s) administered orally once daily
    Other Name: GS-9674
  • Drug: Placebo to match Cilofexor
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Cilofexor 30 mg (Blinded Study Phase)
    Cilofexor 30 mg + placebo to match Cilofexor 100 mg for 12 weeks
    Interventions:
    • Drug: Cilofexor
    • Drug: Placebo to match Cilofexor
  • Experimental: Cilofexor 100 mg (Blinded Study Phase)
    Cilofexor 100 mg + placebo to match Cilofexor 30 mg for 12 weeks
    Interventions:
    • Drug: Cilofexor
    • Drug: Placebo to match Cilofexor
  • Placebo Comparator: Placebo (Blinded Study Phase)
    Placebo to match Cilofexor 30 mg + placebo to match Cilofexor 100 mg for 12 weeks
    Intervention: Drug: Placebo to match Cilofexor
  • 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.
    Intervention: Drug: Cilofexor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 19, 2018)
71
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2016)
75
Estimated Study Completion Date  ICMJE February 2020
Actual Primary Completion Date July 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02943447
Other Study ID Numbers  ICMJE GS-US-427-4024
2016-002443-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP