ong term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary FibrosisTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2011-002766-21-GR
- Lead Sponsor
- Boehringer Ingelheim Hellas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
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.
11. Sexually active men not committing to using condoms during participation in the study (except if their partner is not of childbearing potential) and 3 months after the last intake of BIBF 1120.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess long term safety of treatment with oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF).;Secondary Objective: There are no secondary objectives.;Primary end point(s): Vital signs<br>Physical examination including weight<br>Clinical laboratory tests (haematology and chemistry)<br>Adverse events, serious adverse events and significant adverse events<br>;Timepoint(s) of evaluation of this end point: The safety data will be evaluated during the whole duration of the study and analysed in interim analyses and at the end of the trial. The first Interim analysis will occur when the last patient entered will reach 48 weeks of treatment. Interim analyses will be performed every 48 weeks thereafter.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable