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Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT01170065
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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
 (submitted: March 1, 2019)
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
 (submitted: July 26, 2010)
Forced vital capacity decline [ Time Frame: 3 years average ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Overall Survival [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ]
    Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death. For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
  • Progression-Free Survival [ Time Frame: From first trial drug intake in 1199.35 to disease progression; up to 61.8 months ]
    Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression. For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
  • Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ]
    Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient. Haemoglobin corrected DLCO was calculated for each patient using the following formulae: Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
  • Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ]
    Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented. An exacerbation was defined as otherwise unexplained clinical features occurring within 1 month including all of the following:
    • Progression of dyspnoea over several days to 4 weeks
    • New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit
    • A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of <225 mmHg since the last visit
    • Exclusion of infection based on routine clinical practice and microbiological studies
    • Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
  • Incidence of Patients With at Least One Acute IPF Exacerbation Over Time [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ]
    Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
  • Time to First Acute IPF Exacerbation [ Time Frame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months ]
    Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.
  • Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs [ Time Frame: From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days ]
    Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • Overall survival [ Time Frame: 3 years average ]
  • Progression free survival [ Time Frame: 3 years average ]
  • Diffusing capacity of the lung for carbon monoxide (DLco) decrease [ Time Frame: 3 years average ]
  • Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation [ Time Frame: 3 years average ]
  • Physical examination (vital signs and weight) [ Time Frame: at 1year, 2 years, 3 years ]
  • Frequency of Adverse Events (AEs) [ Time Frame: at 1year, 2 years, 3 years ]
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
  • Drug: BIBF 1120
    Intermediate dose BIBF 1120 twice daily
  • Drug: BIBF 1120
    High dose BIBF 1120 twice daily
  • Drug: BIBF 1120
    Low dose BIBF 1120 twice daily
  • Drug: BIBF 1120
    Low dose BIBF 1120 once daily
Study Arms  ICMJE
  • Experimental: BIBF 1120 low qd
    Low dose BIBF 1120 once daily
    Intervention: Drug: BIBF 1120
  • Experimental: BIBF 1120 low bid
    Low dose BIBF 1120 twice daily
    Intervention: Drug: BIBF 1120
  • Experimental: BIBF 1120 medium bid
    Intermediate dose BIBF 1120 twice daily
    Intervention: Drug: BIBF 1120
  • Experimental: BIBF 1120 high bid
    High dose BIBF 1120 twice daily
    Intervention: Drug: BIBF 1120
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
 (submitted: June 28, 2011)
198
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
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:

  1. Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
  2. Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
  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. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
  2. Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
  3. Women who are 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.

    Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.

  4. Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
  5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
  6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
  7. Known or suspected active alcohol or drug abuse.
  8. Patient not compliant in previous trial, with trial medication or trial visits.
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 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
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 February 2019

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