An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Boehringer Ingelheim Limited0 个研究点目标入组 750 人开始时间: 2012年5月21日最近更新: 2017年5月8日

适应症

试验速览

暂无简介。

•1. Signed Informed Consent consistent with 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 350

•1. AST, ALT > 1.5 fold 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 patient’s 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.

发起方