Status:
TERMINATED
Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
Lead Sponsor:
Gilead Sciences
Conditions:
Primary Sclerosing Cholangitis
Compensated Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis...
Eligibility Criteria
Inclusion
- Key
- 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 \[magnetic resonance imaging (MRI), computed tomography (CT), or Ultrasound\], or a screening FibroScan®, enhanced liver fibrosis (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 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
- Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal (ULN)
- Total 2 milligram/deciliter (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
- Platelet count ≥ 75,000/microliter (μL). Individuals with evidence of high-risk esophageal or gastric varices in the opinion of the investigator are excluded
- Negative anti-mitochondrial antibody
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04060147
Start Date
October 17 2019
End Date
September 2 2021
Last Update
July 27 2023
Active Locations (16)
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1
Arizona Liver Health
Chandler, Arizona, United States, 85224
2
California Liver Research Institute
Pasadena, California, United States, 91105
3
University of California San Francisco, Liver Clinic
San Francisco, California, United States, 94143
4
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States, 33136