to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Forced Vital Capacity decline (slope of decline between study entry and end of
treatment)
Secondary outcome
Overall survival, progression free survival, yearly decline in DLco and IPF
exacerbations
Background summary
Idiopathic Pulmonary Fibrosis is a chronic disease of unknown aetiology that is
characterized by progressive fibrotic destruction of the lung. Currently there
is no drug registered for this fatal disease other than lung transplantation.
BIBF1120 is currently ideveloped to treat IPF in randomized, placebo controlled
trials. Patients who may have experienced benefit from the drug in the
randomized parent trial will be given the possibility to continue the treatment
after the parent trial is completed.
Study objective
to offer continuation of BIBF 1020 treatment for patients with IPF who have
completed a prior clinical trial with that drug.
establish the long term tolerability and safety profile of BIBF 1120 in IPF.
Study design
open label, roll over
Study burden and risks
Before entry in study 1199.35, patients have already been treated with BIBF
1120. Therefore, the possible side effects are made known to them. Liver
function is closely monitored at in between visits. Blood sampling is done by
qualified medical personnel. Currently there is no cure for IPF. The lung
function tests are part of standard practice for this group of patients.
Comeniusstraat 6
1817 MS Alkmaar
NL
Comeniusstraat 6
1817 MS Alkmaar
NL
Listed location countries
Age
Inclusion criteria
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)
Exclusion criteria
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
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 | EUCTR2009-013788-21-NL |
| CCMO | NL32265.100.10 |