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Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

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ClinicalTrials.gov Identifier: NCT04060147
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Compensated Cirrhosis Drug: CILO Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: CILO 30 mg
Participants will receive escalating doses of CILO 30 mg, 60 mg, and 100 mg.
Drug: CILO
Tablets administered orally once daily
Other Names:
  • Cilofexor
  • GS-9674




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: First dose date up to Week 12 plus 30 days ]
  2. Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: First dose date up to Week 12 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

Inclusion Criteria:

  • Diagnosis of large duct PSC based on cholangiogram (magnetic resonance cholangiopancreatography [MRCP], endoscopic retrograde cholangiopancreatography [ERCP], or percutaneous transhepatic cholangiogram [PTC])
  • Individuals have evidence of cirrhosis based on historical liver biopsy, abdominal imaging (MRI, CT, or Ultrasound), or a screening FibroScan®, ELF™, or FibroTest®.
  • Individual has the following laboratory parameters at the Screening visit, as determined by the central laboratory:

    • Estimated glomerular filtration rate (eGFR) > 60 mL/min, as calculated by the Cockcroft-Gault equation
    • ALT ≤ 5 x ULN
    • Total Bilirubin ≤ 1.5 x ULN, except in confirmed cases of Gilbert's syndrome
    • INR ≤ 1.4, unless due to therapeutic anticoagulation
    • Platelet count ≥ 100,000/μL
    • Negative anti-mitochondrial antibody

Exclusion Criteria:

  • Current or prior history of any of the following

    • Decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal hemorrhage
    • Liver transplantation
    • Cholangiocarcinoma or hepatocellular carcinoma (HCC).
  • Model for End-stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
  • Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
  • Current moderate to severely active inflammatory bowel disease (IBD) in the opinion of the investigator

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): NCT04060147


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 ext GILEAD-0 GileadClinicalTrials@gilead.com

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: NCT04060147     History of Changes
Other Study ID Numbers: GS-US-428-5443
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 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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Liver Cirrhosis
Cholangitis
Cholangitis, Sclerosing
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases