Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

NCT03890120 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-428-41942019-000204-14jRCT2080224728
• Study Type: interventional
• Target: 419
• Locations: 15 countries
• Sites: 199

Brief 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).

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96

  Progression of liver fibrosis was defined as having a ≥ 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).

  Blinded Phase Week 96

Secondary Outcomes (12)

• Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase

  First dose date in the Blinded Phase up to 100.3 weeks plus 30 days

• Percentage of Participants Who Experienced TEAEs in The OLE Phase

  First dose date in the OLE Phase up to 45 weeks plus 30 days

• Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase

  First dose date in the Blinded Phase up to 100.3 weeks plus 30 days

• Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase

  First dose date in the OLE Phase up to 45 weeks plus 30 days

• Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96

  Baseline, Blinded Phase Week 96

Study Arms (4)

Cilofexor 100 mg (Blinded Phase)

EXPERIMENTAL

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

Drug: Cilofexor

Placebo (Blinded Phase)

PLACEBO COMPARATOR

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

Drug: Placebo

Cilofexor From Cilofexor 100 mg (OLE Phase)

EXPERIMENTAL

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.

Drug: Cilofexor

Cilofexor From Placebo (OLE Phase)

EXPERIMENTAL

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.

Drug: Cilofexor

Interventions

Cilofexor DRUG

100 mg tablet administered orally once daily

Also known as: GS-9674

Cilofexor 100 mg (Blinded Phase); Cilofexor From Cilofexor 100 mg (OLE Phase); Cilofexor From Placebo (OLE Phase)

Placebo DRUG

Tablet administered orally once daily

Placebo (Blinded Phase)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (201)

Institute For Liver Health

Glendale, Arizona, 85306, United States

Location

The Institute for Liver Heath

Phoenix, Arizona, 85013, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Altman Clinical and Translational Research Institute (Clinic)

La Jolla, California, 92037, United States

Location

Scripps Clinic/Green Hospital

La Jolla, California, 92037, United States

Location

Ruane Clinical Research Group Inc.

Los Angeles, California, 90036, United States

Location

Stanford Hospital

Palo Alto, California, 94025, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of California, Davis Medical Center (study visits)

Sacramento, California, 95817, United States

Location

Sutter Pacific Medical Foundation - California Pacific Medical Center

San Francisco, California, 94107, United States

Location

University of California, San Francisco Liver Clinic

San Francisco, California, 94143, United States

Location

Cedars Sinai Medical Center

West Hollywood, California, 90048, United States

Location

University of Colorado Denver and Hospital

Aurora, Colorado, 80045, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

South Denver Gastroenterology, PC

Englewood, Colorado, 80113, United States

Location

Yale School of Medicine

New Haven, Connecticut, 48109, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, 33136, United States

Location

Advanced Research Institute, Inc

New Port Richey, Florida, 34653, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Northwestern Memorial Hospital; Clinical Research Unit

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center (outpatient clinic)

Chicago, Illinois, 60637, United States

Location

NorthShore University Healthsystem

Evanston, Illinois, 60201, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minnesota Gastroenterology, PA

Maplewood, Minnesota, 55117, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39157, United States

Location

Saint Louis University, Gastroenterology & Hepatology

St Louis, Missouri, 63104, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Rutgers New Jersey Medical School - Doctors Office Center

Newark, New Jersey, 07103, United States

Location

Northwell Health Center for Liver Diseases and Transplantation

Manhasset, New York, 11030, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Icahn School of Medicine at Mount Sinai Beth Israel

New York, New York, 10029, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Center for Liver Disease and Transplantation, Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center - Center for Liver Disease

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Holmes Hospital

Cincinnati, Ohio, 45267, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

University Gastroenterology

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 28204, United States

Location

Rapid City Medical Center, LLP

Rapid City, South Dakota, 57701, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center - Digestive Disease Center

Nashville, Tennessee, 37232, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

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

Dallas, Texas, 75246, United States

Location

Baylor Scott & White Medical Center at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine - Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

Spring Gastroenterology Associates

Humble, Texas, 77338, United States

Location

San Antonio Military Medical Center, Gastro/Hepatology

San Antonio, Texas, 78234, United States

Location

Intermountain Medical Center - Transplant Services

Murray, Utah, 84107, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Verity Research Inc.

Fairfax, Virginia, 22031, United States

Location

Bon Secours Richmond Community Hospital

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University Clinical Research Services Unit

Richmond, Virginia, 23298, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Nepean Hospital

Penrith, New South Wales, 2751, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Coral Sea Clinical Research Institute - Mackay

Auchenflower, Queensland, 4066, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Misericordiae Ltd

South Brisbane, Queensland, 4101, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Hôpital Erasme - ULB

Brussels, 10070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, B-3000, Belgium

Location

Centre Hospitalier Universitaire de Liège Site Sart Tilman

Liège, 4000, Belgium

Location

William Osler Health System - Brampton Civic Hospital

Brampton, L6R 3J7, Canada

Location

University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

Calgary, T2N 4Z6, Canada

Location

University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

Edmonton, T6G 2X8, Canada

Location

Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

Halifax, B3L 1E4, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, L8N 4A6, Canada

Location

McMaster University Medical Center

Hamilton, L8S 4L8, Canada

Location

Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

Montreal, H2X 3J4, Canada

Location

Chronic Viral Illness Service/McGill University Health Centre (MUHC)

Montreal, H4A 3J1, Canada

Location

Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

Toronto, M5G 2C4, Canada

Location

Toronto Liver Centre

Toronto, M6H 3M1, Canada

Location

Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

Vancouver, V5Z 1M9, Canada

Location

(G.I.R.I.) GI Research Institute

Vancouver, V6Z 2K5, Canada

Location

University of Manitoba/Health Sciences Centre

Winnipeg, R3E 3P4, Canada

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Copenhagen University Hospital - Hvidovre

København Ø, DK-2100, Denmark

Location

Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

Helsinki, 00290, Finland

Location

Turku University Hospital, Gastroenterology Outpatient Clinic

Turku, 20520, Finland

Location

Hôpital Saint-Eloi

Montpellier, Herault, 34295, France

Location

CHU Amiens-Picardie Hôpital Sud

Amiens, 80054, France

Location

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

CHRU Lille, 59000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Hôpital Saint-Joseph

Marseille, 13008, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Bordeaux-Hopital Haut-Leveque

Pessac, 33604, France

Location

Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

Reims, 4025, France

Location

CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

CHU de Toulouse Hopital Ranguiel

Toulouse, 31059, France

Location

CHU de Toulouse - Hopital Rangueil

Toulouse, 31300, France

Location

Hopital Paul Brousse

Villejuif, 94800, France

Location

GASTRO-Studien GbR

Berlin, 10825, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Medizinische Hochscule Hannover

Hanover, 30625, Germany

Location

Universitätsklinik Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

Homburg, 66421, Germany

Location

Gastroenterologisch-Hepatologisches Zentrum Kiel

Kiel, 24146, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, 04103, Germany

Location

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim, II. Medizinische Klinik

Mannheim, 68167, Germany

Location

Emek Medical Center

Afula, 1834111, Israel

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 64239, Israel

Location

Hadassah University Hospital Ein Kerem

Jerusalem, 91120, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 62431, Israel

Location

IRCCS Ospedale Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Dipartimento Gastroenterologico e dei Trapianti

Ancona, 60126, Italy

Location

Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

Bologna, 40138, Italy

Location

Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

Milan, 20122, Italy

Location

Medicina Interna 1

Novara, 28100, Italy

Location

Azienda Ospedale Universita Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico P. Giaccone

Palermo, 90127, Italy

Location

Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

Pisa, 56124, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

U.O.C. Gatroenterologia

Rozzano, 20089, Italy

Location

Istituto Clinico Humanitas - Unita Operativa di Epatologia

Rozzano (Milan), 20089, Italy

Location

Chiba University Hospital

Chiba, 260-8670, Japan

Location

Hiroshima University Hospital

Hiroshima, 7348551, Japan

Location

National Hospital Organization Nagasaki Medical Center

Nagasaki, 856-8562, Japan

Location

Okayama University Hospital

Okayama, 7008558, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Osaka University Hospital

Suita, 565-0871, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Teikyo University Hospital

Tokyo, 173-8606, Japan

Location

Ehime University Hospital

Toon-Shi, 791-0295, Japan

Location

Yamagata University Hospital

Yamagata, 9909585, Japan

Location

Auckland City Hospital

Auckland, 92103, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Waikato Hospital

Hamilton, 2001, New Zealand

Location

Hospital General Universitario de Alicante

Alicante, 3010, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28220, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, 36071, Spain

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Universitatsspital Bern

Bern, 3010, Switzerland

Location

Epatocentro Ticino SA

Lugano, 6900, Switzerland

Location

Universitatsspital Zurich

Zurich, 8091, Switzerland

Location

University Hospital Birmingham NHS Foundation Trust

Birmingham, B15 2TT, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G4 0SF, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Aintree University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9NT, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (3)

• Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2.

  PMID: 36922785 BACKGROUND

• Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.

  BACKGROUND

• Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, Joshi D, Salminen K, Yimam K, Isayama H, Montano-Loza AJ, Caldwell S, Danta M, Farkkila M, Gallegos-Orozco JF, Gordon SC, Hinrichsen H, Invernizzi P, Vuppalanchi R, Zhu K, Xu J, Liu X, Lu X, Crans G, Bolbolan S, Boyette L, Alani M, Barchuk WT, Watkins TR, Genovese MC, Bowlus CL. Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):46-58. doi: 10.1016/S2468-1253(25)00208-0. Epub 2025 Oct 28.

  PMID: 41173015 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

cilofexor

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: March 27, 2019
• Primary Completion: November 10, 2022
• Study Completion: December 23, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (3); CA (13); DE (10); FI (2); GB (12); US (82); IT (11); AU (13); IL (8); CH (3); FR (13); ES (11); BE (6); DK (2); JP (10)