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Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)

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ClinicalTrials.gov Identifier: NCT03890120
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Proportion of Participants With Progression of Liver Fibrosis at Week 96 [ Time Frame: Week 96 ]
Progression of liver fibrosis was defined as having a ≥ 1-stage increase in fibrosis according to the Ludwig classification. The proportion of participants with progression of liver fibrosis at Week 96 will be presented.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Gamma Glutamyl Transferase (GGT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Bile Acids at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Composite Endpoint Measuring the Proportion of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification [ Time Frame: Week 96 ]
  • Change From Baseline in Hepatic Collagen Content at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Week 96 [ Time Frame: Week 96 ]
  • Change From Baseline in the Primary Sclerosing Cholangitis Patient-Reported Outcome (PSC-PRO) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Proportion of Participants With Progression to Cirrhosis (Ludwig Fibrosis Stage F4) at Week 96 [ Time Frame: Week 96 ]
  • Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Liver Stiffness by FibroScan® at Week 96 [ Time Frame: Baseline; Week 96 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Gamma Glutamyl Transferase (GGT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Serum Concentrations of Bile Acids at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Hepatic Collagen Content at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Week 96 [ Time Frame: Week 96 ]
  • Change From Baseline in the Primary Sclerosing Cholangitis Patient-Reported Outcome (PSC-PRO) at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Proportion of Participants With Progression to Cirrhosis (Ludwig Fibrosis Stage F4) at Week 96 [ Time Frame: Week 96 ]
  • Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change From Baseline in Liver Stiffness by FibroScan® at Week 96 [ Time Frame: Baseline; Week 96 ]
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 Non-Cirrhotic Adults With Primary Sclerosing Cholangitis
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis
Brief Summary The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other Name: GS-9674
  • Drug: Placebo
    Tablet administered orally once daily
Study Arms  ICMJE
  • Experimental: Cilofexor
    Cilofexor for 96 weeks
    Intervention: Drug: Cilofexor
  • Placebo Comparator: Placebo
    Placebo for 96 weeks
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Diagnosis of large duct PSC
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

    • Platelet count ≥ 150,000/mm^3
    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
    • ALT ≤ 8 x upper limit of the normal range (ULN)
    • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
    • Negative anti-mitochondrial antibody

Key Exclusion Criteria:

  • Current or prior history of any of the following:

    • Cirrhosis
    • Liver transplantation
    • Cholangiocarcinoma or hepatocellular carcinoma (HCC)
    • Ascending cholangitis within 30 days of screening
  • Presence of a percutaneous drain or biliary stent
  • Other causes of liver disease
  • Current or prior history of unstable cardiovascular disease
  • Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   New Zealand,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890120
Other Study ID Numbers  ICMJE GS-US-428-4194
2019-000204-14 ( EudraCT Number )
JapicCTI-194804 ( Registry Identifier: Japan Pharmaceutical Information Center )
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
Plan to Share IPD: No
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 November 2020

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