Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Completed · Phase 3
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01619085
- Run by
- Boehringer Ingelheim
- People needed
- 752
- Starts
- 2012-06-06
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2022-03-25
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
- Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
You may not qualify if…
- 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)
- Bilirubin > 1.5 fold ULN
- Bleeding risk
- Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
- New major thrombo-embolic events developed after completion of the parent trial.
- Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
- 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.
- 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.
- Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
- 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.
Where it is running
- CHLC, EPE - Hospital de Santa Marta — Lisbon, Portugal
- Centro Hospitalar Lisboa Norte Hospital Pulido Valente — Lisbon, Portugal
- Centro Hospitalar Universitário São João,EPE — Porto, Portugal
- Centro Hospitalar de Vila Nova de Gaia — Vila Nova de Gaia, Portugal
- Scientific Research Institute of Pulmonology — Saint Petersburg, Russia
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea
- Gachon University Gil Medical Center — Incheon, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Soonchunhyang University Hospital Seoul — Seoul, South Korea
- The Catholic University of Korea, Yeouido St.Mary's Hospital — Seoul, South Korea
- Hospital Vall d'Hebron — Barcelona, Spain
- Hospital Clínic de Barcelona — Barcelona, Spain
- Hospital de Bellvitge — L'Hospitalet de Llobregat, Spain
- Hospital Nuestra Señora de Valme — Seville, Spain
- Ankara Universitesi Tip Fakultesi — Ankara, Turkey (Türkiye)
- Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul, Turkey (Türkiye)
- Yedikule Gog. Hst. EAH — Istanbul, Turkey (Türkiye)
- Ege Universitesi T.F. — Izmir, Turkey (Türkiye)
- Dr.Suat Seren EAH — Izmir, Turkey (Türkiye)
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom
- Queen Elizabeth Hospital — Birmingham, United Kingdom
- Birmingham Heartlands Hospital — Birmingham, United Kingdom
- St James's University Hospital — Leeds, United Kingdom
- CHUC - Centro Hospitalar e Universitário de Coimbra, EPE — Coimbra, Portugal
Full record on ClinicalTrials.gov
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