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Study of Cilofexor in Adults ...

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

Last Updated: 2023-11-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2022-12-23

Brief Summary

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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).

Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cilofexor 100 mg (Blinded Phase)

Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.

Group Type EXPERIMENTAL

Cilofexor

Intervention Type DRUG

100 mg tablet administered orally once daily

Placebo (Blinded Phase)

Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet administered orally once daily

Cilofexor From Cilofexor 100 mg (OLE Phase)

Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.

Group Type EXPERIMENTAL

Cilofexor

Intervention Type DRUG

100 mg tablet administered orally once daily

Cilofexor From Placebo (OLE Phase)

Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.

Group Type EXPERIMENTAL

Cilofexor

Intervention Type DRUG

100 mg tablet administered orally once daily

Interventions

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Cilofexor

100 mg tablet administered orally once daily

Intervention Type DRUG

Placebo

Tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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GS-9674

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Institute For Liver Health

Glendale, Arizona, United States

Site Status

The Institute for Liver Heath

Phoenix, Arizona, United States

Site Status

Southern California Research Center

Coronado, California, United States

Site Status

Altman Clinical and Translational Research Institute (Clinic)

La Jolla, California, United States

Site Status

Scripps Clinic/Green Hospital

La Jolla, California, United States

Site Status

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

Site Status

Stanford Hospital

Palo Alto, California, United States

Site Status

California Liver Research Institute

Pasadena, California, United States

Site Status

University of California, Davis Medical Center (study visits)

Sacramento, California, United States

Site Status

Sutter Pacific Medical Foundation - California Pacific Medical Center

San Francisco, California, United States

Site Status

University of California, San Francisco Liver Clinic

San Francisco, California, United States

Site Status

Cedars Sinai Medical Center

West Hollywood, California, United States

Site Status

University of Colorado Denver and Hospital

Aurora, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

South Denver Gastroenterology, PC

Englewood, Colorado, United States

Site Status

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States

Site Status

Advanced Research Institute, Inc

New Port Richey, Florida, United States

Site Status

Advanced Medical Research Center

Port Orange, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Site Status

Northwestern Memorial Hospital; Clinical Research Unit

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center (outpatient clinic)

Chicago, Illinois, United States

Site Status

NorthShore University Healthsystem

Evanston, Illinois, United States

Site Status

IU Health University Hospital

Indianapolis, Indiana, United States

Site Status

University of Kansas Hospital

Kansas City, Kansas, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Site Status

Mercy Medical Center

Baltimore, Maryland, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, United States

Site Status

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Minnesota Gastroenterology, PA

Maplewood, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States

Site Status

Saint Louis University, Gastroenterology & Hepatology

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Rutgers New Jersey Medical School - Doctors Office Center

Newark, New Jersey, United States

Site Status