STATUS Terminated

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis (PRIMIS)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Terminated

GILEAD STUDY ID

GS-US-428-4194

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

November 29, 2023

Clinicaltrials.gov ID

NCT03890120

EudraCT ID

2019-000204-14

STUDY DOCUMENTS

View study documents

OVERVIEW

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis (PRIMIS)

PROTOCOL SUMMARY

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Participation requirements

Age

18 years - 75 years

Sex

All

Healthy Volunteers

Study details

Medical Condition

Primary Sclerosing Cholangitis

Gender

N/A

Date

March 2019 - November 2022

Study Type

Interventional

Study Phase

Phase 3

Product

Cilofexor, Placebo

Eligibility information

Inclusion criteria

Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Total bilirubin < 2 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
Negative anti-mitochondrial antibody

Exclusion criteria

Current or prior history of any of the following:
Cirrhosis
Liver transplantation
Cholangiocarcinoma or hepatocellular carcinoma (HCC)
Ascending cholangitis within 30 days of screening
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (201)

Institute For Liver Health

Glendale, Arizona, United States, 85306

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis (PRIMIS)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (201)

Institute For Liver Health

The Institute for Liver Heath

Southern California Research Center

Altman Clinical and Translational Research Institute (Clinic)

Scripps Clinic/Green Hospital

Ruane Clinical Research Group Inc.

Stanford Hospital

California Liver Research Institute

University of California, Davis Medical Center (study visits)

Sutter Pacific Medical Foundation - California Pacific Medical Center

University of California, San Francisco Liver Clinic

Cedars Sinai Medical Center

University of Colorado Denver and Hospital

Peak Gastroenterology Associates

South Denver Gastroenterology, PC

Yale School of Medicine

MedStar Georgetown University Hospital

Schiff Center for Liver Diseases/University of Miami

Advanced Research Institute, Inc

Advanced Medical Research Center

Cleveland Clinic Florida

Piedmont Atlanta Hospital

Northwestern Memorial Hospital; Clinical Research Unit

Rush University Medical Center

University of Chicago Medical Center (outpatient clinic)

NorthShore University Healthsystem

IU Health University Hospital

University of Kansas Hospital

Ochsner Clinic Foundation

Louisiana Research Center, LLC

Mercy Medical Center

Walter Reed National Military Medical Center

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

NECCR PrimaCare Research, LLC

Michigan Medicine - University of Michigan

Henry Ford Hospital

Minnesota Gastroenterology, PA

Mayo Clinic

Southern Therapy and Advanced Research LLC

Saint Louis University, Gastroenterology & Hepatology

University of Nebraska Medical Center

Rutgers New Jersey Medical School - Doctors Office Center

Northwell Health Center for Liver Diseases and Transplantation

NYU Langone Health

Weill Cornell Medical College

Icahn School of Medicine at Mount Sinai Beth Israel

Mount Sinai Medical Center

Center for Liver Disease and Transplantation, Columbia University Medical Center

University of Rochester Medical Center

Montefiore Medical Center

The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

Carolinas Medical Center - Center for Liver Disease

Duke University Medical Center

Wake Forest Baptist Health

Holmes Hospital

Penn State Health Milton S. Hershey Medical Center

Thomas Jefferson University

Einstein Medical Center

Reading Hospital

University Gastroenterology

Medical University of South Carolina

Rapid City Medical Center, LLP

Methodist University Hospital

Vanderbilt University Medical Center - Digestive Disease Center

Texas Clinical Research Institute

The Liver Institute at Methodist Dallas Medical Center

Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas