Overview

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

Status:
Completed
Trial end date:
2021-09-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Criteria
Key Inclusion Criteria:

- 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

Key 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) (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.