The aim of this extension trial is to provide BIBF 1120 treatment for all patients who have completed the 52 weeks treatment period and the follow up period in the phase III placebo controlled parent trial 1199.34, who may have experienced benefit…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
long-term safety
Secondary outcome
Absolute and relative change from baseline in FVC and in % predicted FVC;
On trial survival (all data collected based on fatal adverse events);
Time to first acute IPF exacerbation
Background summary
Idiopathic lung fibrosis is a chronic disease of unknown aetiology that is
characterized by progressive fibrotic desctruction of the lung, resulting in
disabling dyspnea. Up to now there is noglobally accepted treatment for this
fatal disease in NL, except lung transplantation. BIBF 1120
BIBF 1120 is currently being developed for treatment of idiopathic lungfibrosis
and completed phase II with a positive risk/benefit profile. Phase III is
currently ongoing. The most effective dose is 150 mg bid. Positive effects have
been seen for the decrease in reduction of FVC, number of acute IPF
exacerbations, and the quality of life . BIBF 1120 also being developed for
treatment for cancer.
Study objective
The aim of this extension trial is to provide BIBF 1120 treatment for all
patients who have completed the 52 weeks treatment period and the follow up
period in the phase III placebo controlled parent trial 1199.34, who may have
experienced benefit from the trial and wish to continue treatment with BIBF
1120.
The scientific goal is to determine the safety of BIBF 1120 when given for a
long term period to patients with Idiopathic Pulmonary Fibrosis
Study design
open label extension study
Intervention
twice daily BIBF 1120 orally taken
Study burden and risks
lunfunction testing (FVC, standard measure) - each visit
Physical examination including weight, heartrate and bloodpressure - each visit
Blood sampling - each visit
Blood sampling for liver function tests- after visit 6 in between each clinic
visit
ECG - 2 x
Pregnancy test (urine dipstick) each visit if applicable
Comeniusstraat 6
1817 MS Alkmaar
NL
Comeniusstraat 6
1817 MS Alkmaar
NL
Listed location countries
Age
Inclusion criteria
1. Signed Informed Consent consistent with ICH-GCP and local laws prior to trial participation.
2. Patients from trial 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002766-21-NL |
| CCMO | NL40094.100.12 |
| Other | nog niet bekend |