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
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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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,...
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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Weston, Florida 33331
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Austell, Georgia 30106
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Camperdown, New South Wales 2050
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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232 South Woods Mill Road
Chesterfield, Missouri 63017
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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Colchester, Vermont 05446
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Danbury, Connecticut 06810
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Jamaica, New York 11418
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Jasper, Alabama 35501
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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...
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Lexington, Kentucky 40503
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Los Angeles, California 90095
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2011 Tate Springs Rd
Lynchburg, Virginia 24501
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Madison, Wisconsin 53792
(608) 263-2400
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McKinney, Texas 75069
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Minneapolis, Minnesota 55407
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New York, New York 10032
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Phoenix, Arizona 85006
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97210
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Shelbyville, Tennessee 37160
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190 West Broad Street
Stamford, Connecticut 06902
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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Toledo, Ohio 43608
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21732 South Vermont Avenue
Torrance, California 90502
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Wichita, Kansas 67028
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