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Summary

for people ages 40 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Idiopathic Pulmonary Fibrosis Nintedanib

Eligibility

You can join if…

Open to people ages 40 years and up

  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.

You CAN'T join if...

  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.

Locations

  • 1199.33.01030 Boehringer Ingelheim Investigational Site
    San Francisco, California, United States
  • 1199.33.01035 Boehringer Ingelheim Investigational Site
    Stanford, California, United States
  • 1199.33.01026 Boehringer Ingelheim Investigational Site
    Santa Barbara, California, United States
  • 1199.33.01029 Boehringer Ingelheim Investigational Site
    Los Angeles, California, United States
  • 1199.33.01007 Boehringer Ingelheim Investigational Site
    Torrance, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
ID
NCT01619085
Phase
Phase 3
Lead Scientist
Jeffrey Golden
Study Type
Interventional
Last Updated
August 2016