Clinical trial NCT04971785: Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Official title: A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Novo Nordisk A/S
First posted: 2021-07-21
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.


Eligibility criteria: Key Inclusion Criteria:

* Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed.
* Screening laboratory parameters as determined by the study central laboratory:

  * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
  * HbA1c ≤ 10%
  * International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
  * Platelet count ≥ 125,000/uL
  * Alanine aminotransferase (ALT) \< 5 x ULN
  * Serum albumin ≥ 3.5 g/dL
  * Serum alkaline phosphatase (ALP) ≤ 2 x ULN
* Body mass index (BMI) ≥ 23 kg/m\^2 at screening.

Key Exclusion Criteria:

* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding.
* Child-Pugh (CP) score \> 6 at screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation.
* Model for End-stage Liver Disease (MELD) score \> 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation.
* Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.
* Chronic hepatitis B virus (HBV) infection (HBsAg positive), or Chronic hepatitis C virus (HCV) infection (HCV antibody and HCV ribonucleic acid (RNA) positive). Individuals cured of HCV infection less than 2 years prior to the screening visit are not eligible.
* History of liver transplantation.
* Current or prior history of hepatocellular carcinoma (HCC).
* Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (1 unit is equivalent to 12 ounce (oz)/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).

  * For individuals on vitamin E regimen ≥ 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy.
  * For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy.
* History of type 1 diabetes.
* Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy.
* For individuals who have not completed a series of an authorized coronavirus disease 2019 (COVID-19) vaccination regimen prior to screening, a positive result for COVID-19 on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase-polymerase chain reaction (RT-PCR) test.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieve ≥ 1-Stage Improvement in Fibrosis According to the NASH Clinical Research Network (CRN) Classification Without Worsening of NASH in Participants Treated With SEMA + CILO/FIR Versus Placebo
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants Who Achieve ≥1-Stage Improvement in Fibrosis (According to the NASH CRN Classification) Without Worsening of NASH in Participants Treated With SEMA+CILO/FIR Versus SEMA Alone
timeFrame: Week 72
measure: Percentage of Participants With NASH Resolution in Participants Treated with SEMA+CILO/FIR Versus Placebo
timeFrame: Week 72
measure: Percentage of Participants With NASH Resolution In Participants Treated With SEMA+CILO/FIR Versus CILO/FIR Alone
timeFrame: Week 72
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Madison
country: United States
facility: North Alabama Health Research, LLC
state: Alabama
city: Chandler
country: United States
facility: The Institution For Liver Health dba Arizona Liver Health
state: Arizona
city: Chandler
country: United States
facility: Arizona Health Research
state: Arizona
city: Peoria
country: United States
facility: The Institute for Liver Health DBA Arizona Liver Health
state: Arizona
city: Sun City
country: United States
facility: Gastrointestinal Alliance - Sun City
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: The Institution For Liver Health dba Arizona Liver Health
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Diagnostic Center
state: Arkansas
city: Little Rock
country: United States
facility: ARCare Center for Clinical Research
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Fresno
country: United States
facility: University of California, San Francisco - Fresno
state: California
city: La Jolla
country: United States
facility: University of California, San Diego - Altman Clinical and Translational Research Institute
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute (Fibroscan)
state: California
city: Long Beach
country: United States
facility: Digestive Health Research of Southern California
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC Healthcare Consultation II
state: California
city: Los Angeles
country: United States
facility: Biopharma Informatic, LLC
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Poway
country: United States
facility: Cadena Care Institute, LLC
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: Research and Education Inc.
state: California
city: San Diego
country: United States
facility: TriWest Research Associates, LLC
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Liver Clinic
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology at One Health
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Church Street Research Unit
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Fort Myers
country: United States
facility: Southwest General Healthcare Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at the Clinical and Translational Research Building
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Research, INC
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Maya Research Center
state: Florida
city: Hialeah
country: United States
facility: New Generation of Medical Research
state: Florida
city: Homestead
country: United States
facility: Sunbright Health Medical Center
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville-Gastroenterology Emerson
state: Florida
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc
state: Florida
city: Miami
country: United States
facility: G+C Research Group
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/ University of Miami
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Century Research, LLC
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research, Corp
state: Florida
city: Miami
country: United States
facility: International Medical Investigational Centers, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Covenant Metabolic Specialists, LLC
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC
state: Florida
city: Dalton
country: United States
facility: Southeast Clinical Research LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal (GI) Specialists of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Group - Department of Hepatology
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Enterprise Clinical Research Operations
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology Health Partners, PLLC
state: Indiana
city: South Bend
country: United States
facility: Digestive Research Alliance of Michigan
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center, PC
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic PA
state: Kansas
city: Baton Rouge
country: United States
facility: GI Alliance
state: Louisiana
city: Lafayette
country: United States
facility: Combined Gastro Research, LLC
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Oschner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Framingham
country: United States
facility: Greater Boston Gastroenterology
state: Massachusetts
city: South Dartmouth
country: United States
facility: Hawthorn Medical Associates
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Flowood
country: United States
facility: GI Alliance
state: Mississippi
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Columbia
country: United States
facility: GI Associates Research
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Florham Park
country: United States
facility: Digestive Disease Research
state: New Jersey
city: Freehold
country: United States
facility: Allied Health Clinical Research Organization, LLC
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: Center for Research at Southwest Gastroenterology Associates, PC
state: New Mexico
city: Manhasset
country: United States
facility: Northwell Health Center for Liver Diseases
state: New York
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital
state: New York
city: New York
country: United States
facility: The New York - Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology, a Division of Digestive Health Partners, PA
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Transplant and Center for Liver Disease
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Concord
country: United States
facility: Northeast GI Research Division
state: North Carolina
city: Fayetteville
country: United States
facility: Coastal Research Institute
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Carolina's GI Research, LLC
state: North Carolina
city: Columbus
country: United States
facility: Optimed Research
state: Ohio
city: Springboro
country: United States
facility: DSI Research
state: Ohio
city: Westlake
country: United States
facility: Clinical Research Institute of Ohio, LLC
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Columbia Digestive Health Research
state: South Carolina
city: Greenwood
country: United States
facility: Digestive Disease Research Center
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Chattanooga
country: United States
facility: Wake Research - ClinsSearch, LLC
state: Tennessee
city: Johnson City
country: United States
facility: Gastrointestinal Associates of Northeast Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Brownsville
country: United States
facility: South Texas Research Institute
state: Texas
city: Cedar Park
country: United States
facility: GI Alliance
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: GI Alliance
state: Texas
city: Dallas
country: United States
facility: Internal Medicine Digestive and Liver Diseases Clinical Trials
state: Texas
city: Denison
country: United States
facility: Soma Clinical Trials, LLC
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development Cancer Research Center
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Fort Worth
country: United States
facility: GI Alliance
state: Texas
city: Garland
country: United States
facility: GI Alliance
state: Texas
city: Georgetown
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Harlingen
country: United States
facility: Texas Digestive Specialists
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: Liver Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Houston Research Institute
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Katy
country: United States
facility: BioStar Clinical Research Group Inc.
state: Texas
city: Lubbock
country: United States
facility: GI Alliance
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Pasadena
country: United States
facility: Digestive System Healthcare
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic, P.A.
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research, LLC
state: Texas
city: San Marcos
country: United States
facility: GI Alliance (Patients Seen, IP Shipment & Fibroscan)
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Webster
country: United States
facility: GI Alliance
state: Texas
city: Wichita Falls
country: United States
facility: Digestive Health Research of North Texas
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Burlington
country: United States
facility: The University Of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health Clinical Research Services Unit
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Health, Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre (Clayton)
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Brampton
country: Canada
facility: Wlliam Osler Health System - Brampton Civic Hospital
city: Calgary
country: Canada
facility: University of Calgary Liver Unit - Heritage Medical Research Clinic
city: Hamilton
country: Canada
facility: McMaster University Medical Center
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
city: Montreal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de I'Universite de Montreal (CRCHUM)
city: Montreal
country: Canada
facility: Chronic Viral Illness Service, Royal Victoria Hospital, McGill University Health Centre (MUHC)
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
city: Toronto
country: Canada
facility: Toronto Liver Centre
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
city: Vancouver
country: Canada
facility: (G.I.R.I.) Gastrointestinal Research Institute
city: Vanghan
country: Canada
facility: Toronto Digestive Disease Associates Specialty Research
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: Centre Hosptitalier Universitaire d'Angers
city: Chambray-les-Tours
country: France
facility: Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Grenoble Cedex 9
country: France
facility: CHU de Grenoble
city: Lille Cedex
country: France
facility: Hopital Claude Huriez
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Limoges
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: Centre Hospitalier Universitarie de Montpellier - Hospital Saint-Eloi
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hopital L'archet
city: Paris
country: France
facility: Hopital Universitaire Pitie Salpetriere
city: Paris
country: France
facility: Hopitaux de Paris - Hopital Cochin
city: Pessac Cedex
country: France
facility: Hopital Haut Leveque
city: Pessac
country: France
facility: Hopital Beaujon
city: Rennes
country: France
facility: CHU Rennes Pontchaillou
city: Toulouse
country: France
facility: Hopital Rangueil
city: Vandoeuvre les Nancy
country: France
facility: Hopital Brabois Adultes - CHU de Nancy
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital
city: Izunokuni
country: Japan
facility: Juntendo University Shizouka Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Musashino-city
country: Japan
facility: Japanese Red Cross Masashino Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Saga-shi
country: Japan
facility: Saga University Hospital
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Tokyo
country: Japan
facility: Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
city: Toon-Shi
country: Japan
facility: Ehime University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Almeria
country: Spain
facility: Hospital Universitario Torrecardenas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic De Barcelona
city: Madrid
country: Spain
facility: Hospital General Universiatrio Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz Edificio de Malemidad
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostella
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgin del Rocio
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnlo la Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: