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. (see Contacts and Locations)
Verified August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab (GS-6624)
Drug: Placebo to match simtuzumab
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: Up to 254 weeks ] [ 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).

  • PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.


Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    From the date of randomization to the date of death from any cause, assessed up to 254 weeks.

  • All-cause mortality among participants with "high" sLOXL2 at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants 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: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab (GS-6624)
Participants will receive simtuzumab (GS-6624) for up to 254 weeks.
Drug: Simtuzumab (GS-6624)
Simtuzumab (GS-6624) 125 mg/mL single-dose vials administered subcutaneously weekly
Other Name: GS-6624
Placebo Comparator: Placebo to match simtuzumab
Participants will receive placebo to match simtuzumab for up to 254 weeks.
Drug: Placebo to match simtuzumab
Placebo to match simtuzumab single-dose vials administered subcutaneously 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
  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.

    • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
    • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
  • Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769196

  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: Christian Vasquez    805-563-5826    cvasquez@ccsb.org   
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 Withdrawn
Towson, Maryland, United States, 21204
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 Withdrawn
Minneapolis, Minnesota, United States, 55407
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: Rose Smigla    919-681-3866      
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
Contact: Amy Frayser    804-828-7966    afrayser@vcu.edu   
Principal Investigator: Daniel Grinnan         
United States, Washington
Providence Everett Medical Center Recruiting
Everett, Washington, United States, 98201
Contact: Dean Rocco    425-261-3499    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    +33467042020      
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 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 Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: John Jones    +4401515295886    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: Hania Piotrowska    +4401865225205    hania.piotrowska@ouh.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    +4402381208427    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: Lisa Derr    +4401312427195    lisa.derr@nhslothian.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 Director: Thomas O'Riordan, MD Gilead Sciences
  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: August 13, 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 September 14, 2014