Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01170065 |
Recruitment Status :
Completed
First Posted : July 27, 2010
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | July 6, 2010 | |||
First Posted Date ICMJE | July 27, 2010 | |||
Results First Submitted Date ICMJE | September 25, 2017 | |||
Results First Posted Date ICMJE | June 6, 2019 | |||
Last Update Posted Date | June 6, 2019 | |||
Actual Study Start Date ICMJE | June 25, 2010 | |||
Actual Primary Completion Date | September 26, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Annual Rate of Decline in Forced Vital Capacity (FVC) [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ] Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.
For this endpoint reported means represent the adjusted rate.
|
|||
Original Primary Outcome Measures ICMJE |
Forced vital capacity decline [ Time Frame: 3 years average ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF) | |||
Official Title ICMJE | 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 | |||
Brief Summary | The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug. The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF). As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design. |
|||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Pulmonary Fibrosis | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
198 | |||
Original Estimated Enrollment ICMJE |
285 | |||
Actual Study Completion Date ICMJE | September 26, 2016 | |||
Actual Primary Completion Date | September 26, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Portugal, Russian Federation, Spain, United Kingdom | |||
Removed Location Countries | Czech Republic, El Salvador | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01170065 | |||
Other Study ID Numbers ICMJE | 1199.35 2009-013788-21 ( EudraCT Number ) |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Boehringer Ingelheim | |||
Original Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | |||
Current Study Sponsor ICMJE | Boehringer Ingelheim | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Boehringer Ingelheim | |||
Verification Date | February 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |