Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
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ClinicalTrials.gov Identifier: NCT01619085 |
Recruitment Status :
Completed
First Posted : June 14, 2012
Results First Posted : July 26, 2018
Last Update Posted : March 25, 2022
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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First Submitted Date ICMJE | June 6, 2012 | |||
First Posted Date ICMJE | June 14, 2012 | |||
Results First Submitted Date ICMJE | July 2, 2018 | |||
Results First Posted Date ICMJE | July 26, 2018 | |||
Last Update Posted Date | March 25, 2022 | |||
Actual Study Start Date ICMJE | June 6, 2012 | |||
Actual Primary Completion Date | July 5, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Incidence of Adverse Events (AEs) [ Time Frame: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days. ] This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis | |||
Official Title ICMJE | An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | |||
Brief Summary | The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Idiopathic Pulmonary Fibrosis | |||
Intervention ICMJE | Drug: Nintedanib
Nintedanib twice a day
Other Name: BIBF 1120
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Study Arms ICMJE | Experimental: All subjects
patient to receive a capsule containing Nintedanib twice a day
Intervention: Drug: Nintedanib
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Publications * | Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
752 | |||
Original Estimated Enrollment ICMJE |
750 | |||
Actual Study Completion Date ICMJE | February 1, 2021 | |||
Actual Primary Completion Date | July 5, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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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 | Australia, Belgium, Canada, Chile, China, Czechia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Portugal, Russian Federation, Spain, Turkey, United Kingdom, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01619085 | |||
Other Study ID Numbers ICMJE | 1199.33 2011-002766-21 ( EudraCT Number ) |
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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 | Same as current | |||
Current Study Sponsor ICMJE | Boehringer Ingelheim | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | February 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |