Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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.
Clareo Health | Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
