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A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab (GS-6624)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is defined as all-cause mortality or a categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC) up to 182 weeks.


Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    From the date of randomization to the date of death from any cause, assessed up to 182 weeks.

  • PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    A cut-off to classify patients as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.

  • All-cause mortality among subjects with "high" sLOXL2 at baseline [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    A cut-off to classify patients as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab (GS-6624)
Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
Drug: Simtuzumab (GS-6624)
Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
Other Name: GS-6624
Placebo Comparator: Placebo
Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly
Drug: Placebo
Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects from 45 to 85 years of age

    • Definite IPF within 3 years prior to screening
  • Be able to walk at least 50 meters

Exclusion Criteria:

  • Significant diseases other than IPF
  • Obstructive lung disease
  • Aortic aneurysm greater than or equal to 3.5 cm in diameter
  • Listed as active on a lung transplant waiting list
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769196

Contacts
Contact: Tom O'Riordan, MD 206-832-2197 thomas.oriordan@gilead.com
Contact: Selina Bayly 206-256-4956 selina.bayly@gilead.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Tonja Meadows    205-934-7630      
Principal Investigator: Tracy Luckhardt         
United States, Arizona
Arizona Pulmonary Specialists, Ltd. Recruiting
Phoenix, Arizona, United States, 85012
Contact: April Mendoza    602-271-0832      
Principal Investigator: Jeremy Feldman, MD         
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85103
Contact: Veta Markland-Gentles    602-406-5853      
Principal Investigator: Rajeev Saggar, MD         
Arizona Pulmonary Specialists, Ltd. Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Annette Conly    480-657-7254      
Principal Investigator: Jonathan Ruzi, MD         
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Michaele Menghini    480-301-6651    menghini.michaele@mayo.edu   
Principal Investigator: Lewis Wesselius         
The University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Osmara Molina    520-891-6767    omolina@arc.arizona.edu   
Principal Investigator: Gordon Carr         
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Chris Whitehead    858-657-5498    chwhitehead@ucsd.edu   
Principal Investigator: Gordon Yung         
David Geffen School of Medicine at University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Eileen Callahan    310-794-2466    ecallahan@mednet.ucla.edu   
Principal Investigator: Samuel Weigt         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Maya Juarez    916-734-3643      
Principal Investigator: Andrew Chan, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Archer Eller    415-502-1958      
Principal Investigator: Jeffrey Golden, MD         
Sansum Clinic Recruiting
Santa Barbara, California, United States, 93105
Contact: Alexis Donaire    808-898-3602      
Principal Investigator: David Zisman, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Susan Jacobs    650-725-8083      
Principal Investigator: Glenn Rosen, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Susan Jacobs    650-725-8083    ssjpulm@stanford.edu   
Principal Investigator: Glenn Rosen         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Carol Bair    303-398-1912    bairc@njhealth.org   
Principal Investigator: Amy Olson         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06150
Contact: Jean Estrom    203-785-7324    jean.estrom@yale.edu   
Principal Investigator: Danielle Antin-Ozerkis         
United States, Florida
Bay Area Chest Physicians Recruiting
Clearwater, Florida, United States, 33756
Contact: Frank Persechino, RN, BSN    727-631-0779    frank@researchalliance.net   
Principal Investigator: Devendra Amin, MD         
Bay Area Chest Physicians Recruiting
Clearwater, Florida, United States, 33756
Contact: Ann Marie Ramus    727-631-0779      
Principal Investigator: Devendra Amin, MD         
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Pam Schreck    352-294-5195    pschreck@ufl.edu   
Principal Investigator: Pam Schreck         
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Minal Patel    904-244-1106    minal.patel@jax.ufl.edu   
Principal Investigator: Abubakr Bajwa         
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Pamela Long    904-953-7719    long.pamela@mayo.edu   
Principal Investigator: Augustine Lee         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Emmanuelle Simonet    305-243-3728      
Principal Investigator: Marilyn Glassberg, MD         
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Emmanuelle Simonet    305-243-3728    esimonet@med.miami.edu   
Principal Investigator: Marilyn Glassberg         
Central Florida Pulmonary Group, PA Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Sondra Sadler    352-874-1356    sondra.sadler@flhosp.org   
Principal Investigator: Kevin DeBoer         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Mary Bradley    941-917-6164    mary-bradley@smh.com   
Principal Investigator: Raymond Hautamaki         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Brenda Farlow    813-844-3430    bfarlow@tgh.org   
Principal Investigator: Tarik Haddad         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Calvin Killingbeck    954-659-6247    killinc@ccf.org   
Principal Investigator: Franck Rahaghi         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Srihari Veeraraghavan    404-778-5736    veeraraghavan@emory.edu   
Principal Investigator: Megan Filkowski         
Southeastern Lung Care Not yet recruiting
Decatur, Georgia, United States, 30033
Contact: Crystal Motes    770-667-0220    cmotes@csi-research.com   
Principal Investigator: Thomas DeMarini         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Carley Demchuk    773-834-7085      
Principal Investigator: Mary Strek, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Clare Marlin    312-695-2269    clare-murphy@northwestern.edu   
Principal Investigator: Rishi Raj         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Joyce Brown    312-942-6771    joyce_d_brown@rush.edu   
Principal Investigator: Mark Yoder         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Cathy Kalnicky    708-216-2027    ckalnic@lumc.edu   
Principal Investigator: Daniel Dilling         
United States, Iowa
Loess Hills Clinical Research Center Recruiting
Council Bluffs, Iowa, United States, 51503
Contact: Anne Alter    712-352-1015      
Principal Investigator: Jorge Alvarez, MD         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kim Sprenger    319-353-8862    kimberly-sprenger@uiowa.edu   
Principal Investigator: Alicia Gerke         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kimberly Robinson    502-587-8000      
Principal Investigator: John McConnell, MD         
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Heidi Wilson    502-852-0560      
Principal Investigator: Rafael Perez, MD         
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040      
Principal Investigator: Joseph Lasky, MD         
United States, Maryland
John Hopkins University Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Elizabeth Schonhoft    410-502-8686    eheller6@jhmi.edu   
Principal Investigator: Sonye Danoff         
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jennifer Davis    410-328-1473    jdavis2@medicine.umaryland.edu   
Principal Investigator: E. James Britt,         
Pulmonary and Critical Care Associates of Baltimore Recruiting
Towson, Maryland, United States, 21204
Contact: David Highfield    410-494-7921    dhighfield@pccabpa.com   
Principal Investigator: Linda Barr         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maureen Vey    617-667-4708      
Principal Investigator: Zibrak Joseph         
Tufts University School of Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Karen Visnaw    617-636-1334    Kvisnaw@tuftsmedicalcenter.org   
Principal Investigator: Nicholas Hill         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Melissa Smith    617-525-9297    msmith67@partners.org   
Principal Investigator: Hilary Goldberg         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48124
Contact: Krishna Thavarajah    313-916-1130    kthavar1@hfhs.org   
Principal Investigator: Krishna Thavarajah         
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Tommy Goodwin    612-625-7719    goodw020@umn.edu   
Principal Investigator: Hyun Kim         
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: April Hawthorne    952-852-5324    aprilh@mnlungresearch.com   
Principal Investigator: Mitchell Kaye         
The Mayo Clinic in Rochester MN Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Suson Walsh    507-293-0637      
Principal Investigator: Andrew Limper, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Suson Walsh    507-293-0637    walsh.suson@mayo.edu   
Principal Investigator: Andrew Limper         
United States, Missouri
CardioPulmonary Associates Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Sue Merli    314-576-4501    sue.merli@stlukes-stl.com   
Principal Investigator: Neil Ettinger         
Saint Luke's Midwest Pulmonary Consultants Recruiting
Kansas City, Missouri, United States, 64111
Contact: Mindy Peters    816-932-9892      
Principal Investigator: Mark Yagan, MD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aviva Aloush    314-747-0994      
Principal Investigator: Adrian Shifren         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 55905
Contact: Kathy Dickie    603-650-4711      
Principal Investigator: Richard Enelow, MD         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903-0019
Contact: Deborah McCloskey    732-418-8478    mcclosda@umdnj.edu   
Principal Investigator: David Riley         
Pulmonary & Allergy Associates, P.A. Recruiting
Summit, New Jersey, United States, 77901
Contact: Virginia Hala    908-934-0440 ext 1900    virginiah@paamds.com   
Principal Investigator: Sussman, MD         
Pulmonary and Allergy Associates, PA Recruiting
Summit, New Jersey, United States, 07901
Contact: Marissa Rienton-Lim    908-934-0440      
Principal Investigator: Robert Sussman, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Susan Rauch    518-262-6608      
Principal Investigator: Scott Beegle, MD         
Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States, 11418
Contact: Kelly Cervellione    718-206-5800    kcervell@jhmc.org   
Principal Investigator: Craig Thurm         
North Shore University Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Sameer Verma    516-465-5437    sverma3@nshs.edu   
Principal Investigator: Arunabh Talwar         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Nisha Phlip    212-305-7720      
Principal Investigator: David Lederer, MD         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Arika Manapat    212-241-9538    arika.manapat@mssm.edu   
Principal Investigator: Maria Padilla         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Malesa Pereira    646-962-9871    map2061@med.cornell.edu   
Principal Investigator: Ann Tilley         
Highland Hospital Recruiting
Rochester, New York, United States, 14620
Contact: Elizabeth Lyda    585-233-4358    elizabeth_lyda@urmc.rochester.edu   
Principal Investigator: Michael Kallay, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Marguerite Thoma    919-668-4562      
Principal Investigator: Lake Morrison, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Felicia Thompson    513-584-5226      
Principal Investigator: Robert Baughman, MD         
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tammy Roads    513-558-2148    roadst@ucmail.uc.edu   
Principal Investigator: Markus Gutsche, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ron Wehrmann    216-445-0574    wehrmar@ccf.org   
Principal Investigator: Joseph Parambil         
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Rachael Compton    614-366-2361      
Principal Investigator: Namita Sood, MD         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Angela Shoen    937-208-6013    asshoen@mvh.org   
Principal Investigator: Donald Zoz III         
United States, Oregon
The Oregon Clinic, PC Recruiting
Portland, Oregon, United States, 97220
Contact: Mary alice Day    503-963-3182      
Principal Investigator: Thomas Schaumberg, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lisa Gardo    215-615-0276      
Principal Investigator: Maryl Kreider, MD         
Temple University Hospital, Temple Lung Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Melody Santiago    215-707-5029      
Principal Investigator: Francis Cordova, MD         
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lisa Gardo    215-615-0276    lisa.gardo@uphs.upenn.edu   
Principal Investigator: Mary Kreider         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathryn O'Brien    215-503-2113    kathryn.obrien@jefferson.edu   
Principal Investigator: Ross Summer         
University of Pittsburgh Presbyterian - Montefiore Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michelle Meyers    412-692-2149    meyersma@upmc.edu   
Principal Investigator: Daniel Kass,         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Farah Stokes    843-792-3169      
Principal Investigator: Timothy Whelan, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Wendi Mason    615-343-7068      
Principal Investigator: Lisa Lancaster, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Helena Purl    713-798-2400      
Principal Investigator: Zeenat Safdar, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Patrick Carey    801-581-5864      
Principal Investigator: Mary Beth Scholand         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Melodie Mains    703-776-6485    melodie.mains@inova.org   
Principal Investigator: Oksana Shlobin         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Daniel Grinnan         
United States, Washington
Providence Everett Medical Center Recruiting
Everett, Washington, United States, 98201
Contact: Dean Rocco    425-316-5011    dean.rocco@providence.org   
Principal Investigator: Tomasz Ziedalski         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Patricia Berry-Bell    206-221-5180    pberry-bell@medicine.washington.edu   
Principal Investigator: Erika Lease         
United States, Wisconsin
Froedtert Hospital and Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Rachel Harris    414-955-7030    racharris@mcw.edu   
Principal Investigator: Randolph Lipchik         
Australia, New South Wales
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Contact: Kerrie Wade    +61297676334    kerrie.wade@sswahs.nsw.gov.au   
Principal Investigator: Elizabeth Veitch         
Saint Vincents Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Lisa Singleton    +61283823074    lsingleton@stvincents.com.au   
Principal Investigator: Allan Glanville         
Australia, Queensland
Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Sandy Bancroft    +61731395076    sandra_bancroft@health.qld.gov.au   
Principal Investigator: Peter Hopkins         
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Christopher Zappala       chris_zappala@health.qld.gov.au   
Principal Investigator: Christopher Zappala,         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Louise Milazzo    +61882224244    louise.milazzo@health.sa.gov.au   
Principal Investigator: Mark Holmes         
Australia, Victoria
Peninsula Health Recruiting
Frankston, Victoria, Australia, 3199
Contact: Julie Sharp    +61397847371    juliesharp@phcn.vic.gov.au   
Principal Investigator: David Langton         
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Karen Symons    +61390766963    k.symons@alfred.org.au   
Principal Investigator: Ian Glaspole         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Kerry Boughton    +61893461078    kerry.boughton@health.wa.gov.au   
Principal Investigator: Martin Phillips         
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Natalee Lawson    +610892243933    natalee.lawson@health.wa.gov.au   
Principal Investigator: Michael Musk         
Belgium
ULB Erasme Recruiting
Anderlecht, Brussels, Belgium, 1070
Contact: Amand Gheorghita    +3225553985    ghamand@ulb.ac.be   
Principal Investigator: Paul De Vuyst         
Universitair Ziekenhuis Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Yolande Dewandeleer    +3216343122    yolande.dewandeleer@uzleuven.be   
Principal Investigator: Wim Wuyts         
Cliniques Universitaires UCL de Mont-Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Sabine Domecki    +3281423025    sabine.domecki@uclouvain.be   
Principal Investigator: Yves Sibille         
Canada, British Columbia
Kelowna Respiratory and Allergy Clinic Recruiting
Kelowna, British Columbia, Canada, V1Y1E4
Contact: Madeline Ludwig    1 (250) 862-9777    mludwig@icrcl.com   
Principal Investigator: Jeffrey Douglass Rolf         
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Giselle Gerdak    1 (604) 875-5091    giselle.gerdak@vch.ca   
Principal Investigator: Nasreen Khalil         
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Lynda Lazosky    1 (604) 806-8191    llazosky@providencehealth.bc.ca   
Principal Investigator: Christopher Ryerson         
Canada, Ontario
Saint Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Sarah Goodwin    1 (905) 522-1155 ext 36130      
Principal Investigator: Gerard Cox, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Amanda Liu    1 (416) 581-8586    amanda.liu@uhnresearch.ca   
Principal Investigator: Theodore Marras         
Canada, Quebec
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Annie Landry    1 (514) 890-8000 ext 16344    annie.landry.chum@ssss.gouv.qc.ca   
Principal Investigator: Claude Poirier         
Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Quebec City, Quebec, Canada, G1V4G5
Contact: Luce Bouffard    1 (418) 656-8711 ext 2449    luce.bouffard@criucpq.ulaval.ca   
Principal Investigator: Steeve Provencher         
Czech Republic
Fakultní nemocnice Brno Recruiting
Brno, Jihormoravsky Kraj, Czech Republic, 625 00
Contact: Milada Doskova    +420532233198    doskovamilada@seznam.cz   
Principal Investigator: Jana Skricková         
Nemocnice Jihlava Recruiting
Jihlava, Jihormoravsky Kraj, Czech Republic, 689 32
Contact: Zdenek Doležel    +420567157857    dolezelzdenek@seznam.cz   
Principal Investigator: Tomas Snizek         
Krajská nemocnice Liberec a.s. Recruiting
Liberec, Severocesky Kraj, Czech Republic, 460 63
Contact: Jiri Vytiska    +420485312797    jiri.vytiska@nemlib.cz   
Principal Investigator: Jiri Vytiska         
Masarykova nemocnice v Ústí nad Labem o.z. Recruiting
Ústí nad Labem, Severocesky Kraj, Czech Republic, 401 13
Contact: Zdena Moravcova    +420477113496    zdena.moravcova@mnul.cz   
Principal Investigator: Pavel Reiterer         
Fakultní Nemocnice Ostrava Recruiting
Ostrava - Poruba, Severomoravsky Kraj, Czech Republic, 708 52
Contact: Martina Placková    +420597372240    martina.plackova@fno.cz   
Principal Investigator: Martina Placková         
Fakultní nemocnice Plzen Recruiting
Plzen, Zapadocesky Kraj, Czech Republic, 305 99
Contact: Ivana Spevackova    +420377402238    spevackovai@fnplzen.cz   
Principal Investigator: Radka Bittenglova         
Thomayerova nemocnice Recruiting
Prague 4 - Krc, Czech Republic, 140 59
Contact: Martina Vasakova    +420261082372    martina.vasakova@ftn.cz   
Principal Investigator: Martina Vasakova         
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, Alsace, France, 67091
Contact: Khaled Bennedif    +33369550345    khaled.bennedif@chru-strasbourg.fr   
Principal Investigator: Romain Kessler         
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou Recruiting
Rennes cedex 9, Bretagne, France, 35033
Contact: Karen Rousseau    +33299289795    ide-pneumo-arc@chu-rennes.fr   
Principal Investigator: Stéphane Jouneau         
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau Recruiting
Tours Cedex 9, Centre, France, 37044
Contact: Abder El Houfia    +3324747474772438    a.elhoufia@chu-tours.fr   
Principal Investigator: Sylvain Marchand-Adam         
Centre Hospitalier Universitaire Hôpital Avicenne Recruiting
Bobigny Cedex, Ile-de-france, France, 93009
Contact: Dominique Valeyre    +33148955121    dominique.valeyre@avc.aphp.fr   
Principal Investigator: Dominique Valeyre         
Hôpital Bichat-Claude Bernard Recruiting
Paris, Ile-de-france, France, 75018
Contact: Loubna Alavoine    +3314025714849    loubna.alavoine@bch.aphp.fr   
Principal Investigator: Bruno Crestani         
HEGP Recruiting
Paris Cedex 15, Ile-de-france, France, 75908
Contact: Dominique Israel-Biet    +33156093489    dominique.israel-biet@egp.aphp.fr   
Principal Investigator: Dominique Israel-Biet         
Hôpital Arnaud de Villeneuve Recruiting
Montpellier cedex 5, Languedoc-roussillon, France, 34295
Contact: Isabella Vachier         
Principal Investigator: Arnaud Bourdin         
Hôpital Larrey, CHU de Toulouse, Service de Pneumologie Not yet recruiting
Toulouse cedex 9, Midi-pyrenees, France, 31059
Contact: Frédérique Legenne    +33567771793    legenne.f@chu-toulouse.fr   
Principal Investigator: Grégoire Prevot,         
Hôpital Albert Calmette Recruiting
Lille cedex, Nord Pas-de-calais, France, 59037
Contact: Marie-Aline Moulart    +3332044594830033    m-moulart@chru-lille.fr   
Principal Investigator: Benoît Wallaert         
Centre Hospitalier Universitaire de Nice-Hôpital Pasteur Recruiting
Nice CEDEX 1, Poitou-charentes, France, 06002
Contact: Jennifer Griffonnet    +3349203828127795    griffonnet.j@chu-nice.fr   
Principal Investigator: Charles Marquette         
Centre Hospitalier Universitaire Hôpital Nord Recruiting
Marseille Cedex 20, Provence Alpes Cote D'azur, France, 13015
Contact: Pascal Chanez       pascal.chanez@ap-hm.fr   
Principal Investigator: Pascal Chanez         
Centre Hospitalier Universitaire Grenoble Hopital Michalon Recruiting
Grenoble Cedex 9, Rhone-Alpes, France, 38043
Contact: Marie Jondot       mjondot@chu-grenoble.fr   
Principal Investigator: Christophe Pison         
Hôpital Louis Pradel Recruiting
Bron, Rhone-aples, France, 69677
Contact: Raphaële Guelminger    +33472357074    raphaele.guelminger@chu-lyon.fr   
Principal Investigator: Jean-François Cordier         
Germany
Universität Freiburg, Klinikum, Abt für Pneumologie Recruiting
Freiburg, Baden-wuerttemberg, Germany, 79106
Contact: Bibiane Söllner    +4976127037090    bibiane.soellner@uniklinik-freiburg.de   
Principal Investigator: Joachim Müller-Quernheim         
Thoraxklinik am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-wuerttemberg, Germany, 69126
Contact: Claudia Bauer    +4962213968217    claudia.bauer@thoraxklinik-heidelberg.de   
Principal Investigator: Michael Kreuter         
Ruhrlandklinik Recruiting
Mannheim, Baden-wuerttemberg, Germany, 68165
Contact: Claudia Helmkamp       HelmkampClaudia@praintl.com   
Principal Investigator: Ulrich Costabel         
Klinikum Großhadern der Ludwig-Maximilians-Universität München Recruiting
München, Bayern, Germany, 81377
Contact: Franziska Ihle    +00498970953090    franziska.ihle@med.uni-muenchen.de   
Principal Investigator: Claus Neurohr         
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH Recruiting
Giessen, Hessen, Germany, 35392
Contact: Sabine Heinemann    +4964198542558    sabine.heinemann@innere.med.uni-giessen.de   
Principal Investigator: Andreas Günther, MD         
Lungenfachklinik Immenhausen Not yet recruiting
Immenhausen, Hessen, Germany, 34376
Contact: Nicole Vorreiter    +495673501448    nvorreiter@lungenfachklinik-immenhausen.de   
Principal Investigator: Peter Hammerl,         
Medizinische Hochschule Hannover Recruiting
Hanover, Niedersachsen, Germany, 30625
Contact: Rabea Gatzke    +4905115323454    pneumologie@mh-hannover.de   
Principal Investigator: Tobias Welte         
Fachkrankenhaus Coswig Recruiting
Coswig, Sachsen, Germany, 01640
Contact: Ursula Rohs    +490352365207    studkoord@fachkrankenhaus-coswig.de   
Principal Investigator: Gert Höffken         
Universitätsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Patricia Berger    +00493419712674    patricia.berger@medizin.uni-leipzig.de   
Principal Investigator: Hubert Wirtz         
Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn Not yet recruiting
Berlin, Germany, 14165
Contact: Jacqueline Päpke    +4930810264161    jacqueline.paepke@helios-kliniken.de   
Principal Investigator: Niclas Schönfeld,         
Israel
Soroka University Medical Center Recruiting
Beer Sheva, Beersheba, Israel, 84100
Contact: Tamar Gibor    +97286244245    tamar.gibor@gmail.com   
Principal Investigator: Nimrod Maimon         
Chaim Sheba Medical Center Recruiting
Tel Hashomer, Tel Aviv, Israel, 52621
Contact: Pnina Yaron    +97235302328    pnina.yaron@sheba.health.gov.il   
Principal Investigator: Issahar Ben-Dov         
Hadassah-Hebrew University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Elat Bardach    +972507874654    elat@hadassah.org.il   
Principal Investigator: Raphael Breuer         
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Oli Berkov    97297472161    oli.berkov@clalit.org.il   
Principal Investigator: David Shitrit         
Rabin Medical Center Recruiting
Petach Tikvah, Israel, 49100
Contact: Liora Yehoshua    +97239377214    lioray@clalit.org.il   
Principal Investigator: Mordechai Reuben Kramer         
Italy
Ospedale "G.B.Morgagni - L. Pierantoni" Not yet recruiting
Forlì, Forli-cesena, Italy, 47100
Contact: Sara Tomassetti    +00390543735042    s.tomassetti@ausl.fo.it   
Principal Investigator: Venerino Poletti         
Azienda Ospedaliera San Gerardo di Monza Recruiting
Monza, Monza E Brianza, Italy, 20052
Contact: Almerico Marruchella    +390392339040    amarruchella@qubisoft.it   
Principal Investigator: Alberto Pesci         
Azienda Ospedaliera S. Luigi Regione Gonzole Not yet recruiting
Orbassano, Torino, Italy, 10043
Contact: Elvira Rizza    +390119026413    elvisdanza@yahoo.it   
Principal Investigator: Carlo Albera         
Policlinico Universitario di Catania Not yet recruiting
Catania, Italy, 95123
Contact: Silvia Puglisi       silviapuglisi@fastwebnet.it   
Principal Investigator: Carlo Vancheri         
San Giuseppe Hospital, Dept. of Internal Medicine Not yet recruiting
Milano, Italy, 20132
Contact: Mara Cattaneo    +390286994127    mara.cattaneo@libero.it   
Principal Investigator: Sergio Harari         
Azienda Ospedaliero-Universitaria Policlinico di Modena Not yet recruiting
Modena, Italy, 41100
Contact: Stefania Cerri    +39 0594225335    stefania.cerri@unimore.it   
Principal Investigator: Fabrizio Luppi         
AORN Monaldi Not yet recruiting
Napoli, Italy, 80131
Contact: Maria Luisa Bocchino    +300817062773    marialuisa.bocchino@unina.it   
Principal Investigator: Alessandro Sanduzzi Zamparelli         
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT) Not yet recruiting
Palermo, Italy, 90127
Contact: Adriana Callari    +390912192489    acallari@ismett.edu   
Principal Investigator: Patrizio Vitulo         
Fondazione IRCCS Policlinico S. Matteo Not yet recruiting
Pavia, Italy, 27100
Contact: Giovanna Zacchetti       giovanna.zacchetti@libero.it   
Principal Investigator: Maurizio Luisetti         
Fondazione PTV - Policlinico Tor Vergata Not yet recruiting
Roma, Italy, 00133
Contact: Cesare Saltini    +390620902789    saltini@med.uniroma2.it   
Principal Investigator: Cesare Saltini         
Policlinico Le Scotte Recruiting
Siena, Italy, 53100
Contact: Rosa Metella Refini    +390577586711    refini@unisi.it   
Principal Investigator: Rottoli Paola         
Ospedale di Cattinara Not yet recruiting
Trieste, Italy, 34149
Contact: Annalisa Gasparotto    +390403994667    gasparottoannalisa@hotmail.com   
Principal Investigator: Marco Confalonieri         
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Young Mi Hwang    +82326216374    hym0414@naver.com   
Principal Investigator: Choon-Sik Park         
Gachon University Gil Medical Center Recruiting
Incheon, Gyeonggi-Do, Korea, Republic of, 405-760
Contact: Miyoung Myoung    +82104609457    mmy5737@hanmail.net   
Principal Investigator: Sung Hwan Jeong         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jong Sun Park    +82317877054    jspark.im@gmail.com   
Principal Investigator: Jong Sun Park         
Samsung Medical Center Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 135-710
Contact: Kyung Ui Hwang    +82234106488    ku.hwang@samsung.com   
Principal Investigator: Man Pyo Chung         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Eun Hee Song    +82220720651    julie0315@daum.net   
Principal Investigator: Young Whan Kim         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sul-Hwa Kim    +82230107365    irbksh@amc.seoul.kr   
Principal Investigator: Dong Soon Kim         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Mija Kim    +8229205439    01692353168@hanmail.net   
Principal Investigator: Kwang Ho In         
Poland
10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Contact: Iwona Patyk    +48504139496    iwonapatyk@yahoo.fr   
Principal Investigator: Cezary Rybacki         
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Recruiting
Lódz, Lodzkie, Poland, 90-153
Contact: Sebastian Majewski    +48604518101    sebastian.majewski@umed.lodz.pl   
Principal Investigator: Wojciech Piotrowski         
Instytut Gruzlicy i Chorób Pluc Recruiting
Warszawa, Mazowieckie, Poland, 01-138
Contact: Katarzyna Lewandowska    +48224312262    k.lewandowska@igichp.edu.pl   
Principal Investigator: Jan Kus         
Uniwersyteckie Centrum Kliniczne Not yet recruiting
Gdansk, Pomorskie, Poland, 80-952
Contact: Alicja Sieminska    +48583491625    asieminska@gumed.edu.pl   
Principal Investigator: Ewa Jassem         
Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach Recruiting
Zabrze, Slaskie, Poland, 41-803
Contact: Joanna Gregorczyk    +48323732235    ftpulmza@sum.edu.pl   
Principal Investigator: Jerzy Kozielski         
Spain
Hospital Quirón Madrid Recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Contact: José Echave-Sustaeta María-Tomé    +34914521917    jmechave.mad@quiron.es   
Principal Investigator: José Echave-Sustaeta María-Tomé         
Hospital Clínic i Provincial Recruiting
Barcelona, Spain, 08036
Contact: Gemma Lopez    +34932275540    estudis.clinics@gmail.com   
Principal Investigator: Antoni Xaubet         
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08025
Contact: Diego Castillo    +34935565972    dcastillo@santpau.cat   
Principal Investigator: Diego Castillo         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Mara Antonia Ramón    +34932746208    maramon@vhebron.net   
Principal Investigator: Ferran Morell         
Hospital Universitario La Princesa Recruiting
Madrid, Spain, 28006
Contact: Julio Ancochea    +34915202277    juli119@separ.es   
Principal Investigator: Julio Ancochea,         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Javier de Miguel-Díez    +34915868328    jmiguel.hgugm@salud.madrid.org   
Principal Investigator: Javier de Miguel-Díez         
Hospital Universitario Virgen del Rocio Not yet recruiting
Sevilla, Spain, 41013
Contact: José Antonio Rodríguez Portal    +34955013170    jarportal@ecua.es   
Principal Investigator: José Antonio Rodríguez Portal         
Switzerland
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact: Sarah Pellet    +41714943692    sarah.pellet@kssg.ch   
Principal Investigator: Martin Brutsche,         
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) Recruiting
Lausanne, Vaud, Switzerland, CH 1011
Contact: Laurent Nicod    +410213141379    laurent.nicod@chuv.ch   
Principal Investigator: Laurent Nicod         
Universitätsspital Basel Recruiting
Basel, Switzerland, 4031
Contact: Sandra Kunze    +0041612655184    sandra.kunze@usb.ch   
Principal Investigator: Michael Tamm         
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, England, United Kingdom, B9 5SS
Contact: Sherwood Burge    +4401214240734    sherwood.burge@heartofengland.nhs.uk   
Principal Investigator: Sherwood Burge         
Southmead Hospital Recruiting
Bristol, England, United Kingdom, BS10 5NB
Contact: Deborah Warbrick    +441173235838    deborah.warbrick@nbt.nhs.uk   
Principal Investigator: Ann Millar         
Papworth Hospital Recruiting
Cambridge, England, United Kingdom, CB23 3RE
Contact: Angelique Laubscher    +4407919366577    alaubscher@cambridge-clinical-research.co.uk   
Principal Investigator: Helen Parfrey         
Castle Hill Hospital Recruiting
Cottingham, England, United Kingdom, HU16 5JQ
Contact: Jackie Mower    +441482624009    jackie.mower@hey.nhs.uk   
Principal Investigator: Simon Hart         
Glenfield Hospital Recruiting
Leicester, England, United Kingdom, LE3 9QP
Contact: Nicola Goodman    +4401162583067    nicola.goodman@uhl-tr.nhs.uk   
Principal Investigator: Sanjay Agrawal,         
Aintree University Hospitals NHS Foundation Trust Not yet recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: John Jones    +4401515292783    john.jones@aintree.nhs.uk   
Principal Investigator: Lisa Spencer         
London Chest Hospital Not yet recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Anne Zak    +4402078825657    a.zak@qmul.ac.uk   
Principal Investigator: Neil Barnes         
Royal Brompton Hospital Recruiting
London, England, United Kingdom, SW3 6NP
Contact: Una Fraser    +44020735281214152    u.fraser@rbht.nhs.uk   
Principal Investigator: Toby Maher         
University Hospital of South Manchester NHS Foundation Trust Recruiting
Manchester, England, United Kingdom, M23 9LT
Contact: Karen Rhodes    +4401612916    karen.rhodes@uhsm.nhs.uk   
Principal Investigator: Colm Leonard         
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PD
Contact: Richard Gisli Jenkins    +441158231711    gisli.jenkins@nottingham.ac.uk   
Principal Investigator: Richard Gisli Jenkins,         
Churchill Hospital Recruiting
Oxford, England, United Kingdom, OX3 7LE
Contact: Rachel Hoyles    +4401865225223    rachel.hoyles@orh.nhs.uk   
Principal Investigator: Rachel Hoyles,         
Northern General Hospital Recruiting
Sheffield, England, United Kingdom, S5 7AU
Contact: John Humphreys    4401142713339    john.humphreys@sth.nhs.uk   
Principal Investigator: Moira Whyte         
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Louise Stanley    +442380794479    louise.stanley@uhs.nhs.uk   
Principal Investigator: Sophie Fletcher,         
Norfolk and Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Andrew Wilson    +4401603591257    a.m.wilson@uea.ac.uk   
Principal Investigator: Andrew Wilson,         
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Scotland, United Kingdom, EH16 4TJ
Contact: Dorothy Aitken    +441312423333    dorothy.aitken@luht.scot.nhs.uk   
Principal Investigator: Nikhil Hirani         
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Liz Lennon    +4401412329515    elizabeth.lennon@ggc.scot.nhs.uk   
Principal Investigator: George Chalmers         
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Ganesh Raghu, MD, FCCP, FACP University of Washington
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01769196     History of Changes
Other Study ID Numbers: GS-US-322-0207, 2012-001571-36
Study First Received: January 14, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Idiopathic
Pulmonary
Fibrosis
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 22, 2014