Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis



Status:Active, not recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:2/1/2019
Start Date:June 6, 2012
End Date:March 4, 2019

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An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in
patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the
follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and
1199.34), who wish to continue treatment with BIBF 1120.


Inclusion criteria:

1. Signed Informed Consent consistent with International Conference on Harmonisation-Good
Clinical Practices (ICH-GCP) and local laws prior to trial participation.

2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
and performed the follow-up visit.

Exclusion criteria:

1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper
Limit of Normal (ULN) (Patients who completed the parent trial with transaminase
values > 1.5 fold ULN but < 3 fold ULN are considered eligible)

2. Bilirubin > 1.5 fold ULN

3. Bleeding risk

4. Planned major surgery within the next 3 months, including lung transplantation, major
abdominal or major intestinal surgery.

5. New major thrombo-embolic events developed after completion of the parent trial.

6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.

7. Usage of any investigational drug after completion of the parent trial or planned
usage of a specific investigational drug during the course of this trial.

8. A disease or condition which in the opinion of investigator may put the patient at
risk because of participation in this trial or limit the patients' ability to
participate in this trial.

9. Alcohol or drug abuse which in the opinion of the investigator would interfere with
trial participation.

10. Pregnant women or women who are breast feeding or of child bearing potential not using
two effective methods of birth control (one barrier and one highly effective
non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it
until 3 months after end of treatment.
We found this trial at
38
sites
Camperdown, New South Wales 2050
8650
mi
from
Camperdown,
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
609
mi
from
Chicago, IL
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
1116
mi
from
Falls Church, VA
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
400
mi
from
Longview, TX
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
618
mi
from
Nashville, TN
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
1424
mi
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Providence, RI
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
571
mi
from
San Antonio, TX
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Weston, Florida 33331
1300
mi
from
Weston, FL
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?
mi
from
Albany, NY
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Austell, Georgia 30106
786
mi
from
Austell, GA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
1063
mi
from
Charleston, SC
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232 South Woods Mill Road
Chesterfield, Missouri 63017
402
mi
from
Chesterfield, MO
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
726
mi
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Cincinnati, OH
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Colchester, Vermont 05446
1357
mi
from
Colchester, VT
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
349
mi
from
Dallas, TX
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Danbury, Connecticut 06810
1317
mi
from
Danbury, CT
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Jamaica, New York 11418
1295
mi
from
Jamaica, NY
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Jasper, Alabama 35501
649
mi
from
Jasper, AL
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
1393
mi
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Lebanon, NH
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Lexington, Kentucky 40503
724
mi
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Lexington, KY
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Los Angeles, California 90095
1168
mi
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Los Angeles, CA
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2011 Tate Springs Rd
Lynchburg, Virginia 24501
1020
mi
from
Lynchburg, VA
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
574
mi
from
Madison, WI
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McKinney, Texas 75069
321
mi
from
McKinney, TX
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Minneapolis, Minnesota 55407
550
mi
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Minneapolis, MN
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New York, New York 10032
1290
mi
from
New York, NY
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
1223
mi
from
Philadelphia, PA
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Phoenix, Arizona 85006
851
mi
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Phoenix, AZ
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
974
mi
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Pittsburgh, PA
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Portland, Oregon 97210
1385
mi
from
Portland, OR
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San Francisco, California 94143
1341
mi
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San Francisco, CA
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Santa Barbara, California 93105
1242
mi
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Santa Barbara, CA
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Shelbyville, Tennessee 37160
?
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Shelbyville, TN
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190 West Broad Street
Stamford, Connecticut 06902
1311
mi
from
Stamford, CT
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
1329
mi
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Stanford, CA
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Toledo, Ohio 43608
805
mi
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Toledo, OH
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21732 South Vermont Avenue
Torrance, California 90502
1175
mi
from
Torrance, CA
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Wichita, Kansas 67028
46
mi
from
Wichita, KS
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