Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Primary Sclerosing Cholangitis Compensated Cirrhosis Liver Cirrhosis Cholangitis Cholangitis, Sclerosing Fibrosis CILO CILO 30 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis PSC based on cholangiogram (magnetic resonance cholangiopancreatography [MRCP], endoscopic retrograde cholangiopancreatography [ERCP], or percutaneous transhepatic cholangiogram [PTC]) or liver biopsy
  • 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 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
  • INR ≤ 1.4, unless due to therapeutic anticoagulation
  • Platelet count ≥ 75,000/μL. Individuals with evidence of high-risk esophageal or gastric varices in the opinion of the investigator are excluded
  • Negative anti-mitochondrial antibody

You CAN'T join if...

  • 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) (including ulcerative colitis, Crohn's disease, and indeterminate colitis).
  • Note: Individuals with IBD who currently have an external ostomy bag and/or proctocolectomy are not subject to this exclusion criterion and need not undergo IBD Symptom Severity Assessment.

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

Locations

  • University of California San Francisco, Liver Clinic accepting new patients
    San Francisco California 94143 United States
  • California Liver Research Institute accepting new patients
    Pasadena California 91105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04060147
Phase
Phase 1
Study Type
Interventional
Last Updated