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 |
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.
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
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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