A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis
- Conditions
- lung fibrosis of unknown origin10038716
- Registration Number
- NL-OMON34511
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
1. patients with primary diagnosis of IPF, who are willing to continue trial medication
2. written informed consent signed prior to entry into the study, in accordance with ICH-GCP
3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
1. any disease that may put the patient at risk when participating in this trial
2. participation in another experimental trial in the last 8 weeks
3. women of breast feeding or of child bearing potential, not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
4. sexually active males not comitting to using condoms during the course of the study and at least 10 weeeks after the end of active therapy.
5. patients who require full dose anticoagulation or antiplatelets
6. known or suspected active alcohol or drug abuse
7. patients not compliant in parent trial, with trial medication or visits
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Forced Vital Capacity decline (slope of decline between study entry and end of<br /><br>treatment)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, progression free survival, yearly decline in DLco and IPF<br /><br>exacerbations</p><br>