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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 : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
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 June 9, 2021
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
 (submitted: July 2, 2018)
Incidence of Adverse Events (AE) [ Time Frame: From first drug administration until treatment period, in total up to 56.3 months. ]
This is the measure for percentage of patients with adverse events observed during the trial. The incidence of AEs (% 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  ICMJE
 (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 ]
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
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE Drug: BIBF 1120
BIBF 1120 Bis in die (twice a day)
Study Arms  ICMJE Experimental: BIBF 1120
patient to receive a capsule containing BIBF 1120 twice a day
Intervention: Drug: BIBF 1120
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
752
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
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:

  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  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP