Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

• ClinicalTrials.gov Identifier: NCT01619085
• Recruitment Status: Completed
• First Posted: June 14, 2012
• Results First Posted: July 26, 2018
• Last Update Posted: March 25, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: June 6, 2012
• First Posted Date: June 14, 2012
• Results First Submitted Date: July 2, 2018
• Results First Posted Date: July 26, 2018
• Last Update Posted Date: March 25, 2022
• Actual Study Start Date: June 6, 2012
• Actual Primary Completion Date: July 5, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2022)

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.

Original Primary Outcome Measures (submitted: June 12, 2012)

• Aspartate aminotransferase [ Time Frame: 312 weeks ]
• Total protein [ Time Frame: 312 weeks ]
• Alkaline phosphatase [ Time Frame: 312 weeks ]
• Total bilirubin [ Time Frame: 312 weeks ]
• International normalized ratio [ Time Frame: 312 weeks ]
• Partial thromboplastin time [ Time Frame: 312 weeks ]
• Red blood cell count [ Time Frame: 312 weeks ]
• Haemoglobin [ Time Frame: 312 weeks ]
• Haematocrit [ Time Frame: 312 weeks ]
• Mean corpuscular volume [ Time Frame: 312 weeks ]
• White blood cell count including differential [ Time Frame: 312 weeks ]
• Platelet count [ Time Frame: 312 weeks ]
• Serious Adverse Events [ Time Frame: 312 weeks ]
• Significant adverse events [ Time Frame: 312 weeks ]
• Blood Pressure [ Time Frame: 312 weeks ]
• Creatinine [ Time Frame: 312 weeks ]
• Alanine aminotransferase [ Time Frame: 312 weeks ]
• All Adverse Events [ Time Frame: 312 weeks ]
• Pulse rate [ Time Frame: 312 weeks ]
• Weight [ Time Frame: 312 weeks ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

Drug: Nintedanib

Nintedanib twice a day

Other Name: BIBF 1120

Study Arms

Experimental: All subjects

patient to receive a capsule containing Nintedanib twice a day

Intervention: Drug: Nintedanib

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 1, 2018): 752
• Original Estimated Enrollment (submitted: June 12, 2012): 750
• Actual Study Completion Date: February 1, 2021
• Actual Primary Completion Date: July 5, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Exclusion criteria:

1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (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 patients' 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT01619085
• Other Study ID Numbers: 1199.33; 2011-002766-21 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: February 2022