Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis
NCT ID: NCT04060147
Last Updated: 2023-07-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2019-10-17
2021-09-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
NCT03890120
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
NCT02943460
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
NCT02943447
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
NCT02808312
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
NCT04024813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cilofexor
Participants will receive escalating doses of cilofexor 30 mg, 60 mg, and 100 mg.
Cilofexor
Tablets administered orally once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cilofexor
Tablets administered orally once daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Liver Health
Chandler, Arizona, United States
California Liver Research Institute
Pasadena, California, United States
University of California San Francisco, Liver Clinic
San Francisco, California, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Minnesota Gastroenterology, PA
Maplewood, Minnesota, United States
Northwell Health Center for Liver Diseases and Transplantation
Manhasset, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
VCU Clinical Research Services Unit (CRSU) [Patient Site Address]
Richmond, Virginia, United States
University of Washington at Harborview Medical Center
Seattle, Washington, United States
Liver Institute Northwest
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Levy C, Caldwell S, Mantry P, Luketic V, Landis CS, Huang J, Mena E, Maheshwari R, Rank K, Xu J, Malkov VA, Billin AN, Liu X, Lu X, Barchuk WT, Watkins TR, Chung C, Myers RP, Kowdley KV. Cilofexor in Patients With Compensated Cirrhosis Due to Primary Sclerosing Cholangitis: An Open-Label Phase 1B Study. Clin Transl Gastroenterol. 2024 Aug 1;15(8):e00744. doi: 10.14309/ctg.0000000000000744.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-428-5443
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.