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Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)

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: NCT01417156
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 16, 2011
Results First Submitted Date  ICMJE October 25, 2016
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
Incidence of Overall Adverse Events [ Time Frame: First drug administration until end of treatment, up to 5 years ]
Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Annual Rate of Decline in Forced Vital Capacity (FVC). [ Time Frame: Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years ]
    The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within−patient errors are modelled by an Unstructured variance−covariance matrix. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix. The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data.
  • Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [ Time Frame: Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years ]
    Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height & random effect of patient specific intercept & time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance−covariance matrix. mmHg: millimeters of mercury
  • Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF. [ Time Frame: First drug administration until end of treatment, up to 5 years ]
    The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.
  • Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234. [ Time Frame: Week 234 ]
    The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
  • Forced Vital Capacity decline (mL/year) [ Time Frame: From baseline up to 5 years ]
  • Hemoglobin (Hb) corrected diffusing capacity for carbon monoxide (DLco) decline (mL/min/mmHg/year) [ Time Frame: From baseline up to 5 years ]
  • Acute exacerbations of Idiopathic Pulmonary Fibrosis (IPF) (Frequency and Time to first occurrence) [ Time Frame: up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
Official Title  ICMJE A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis
Brief Summary

Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).

Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: Nintedanib
    150 mg bid
  • Drug: Pirfenidoneone
    Existing treatment
Study Arms  ICMJE Experimental: All patients
Interventions:
  • Drug: Nintedanib
  • Drug: Pirfenidoneone
Publications * Not Provided

*   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: August 15, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Written informed consent consistent with Good Clinical Practice (GCP) signed prior to entry into the study
  2. Completion of 1199.31 study and still under treatment with pirfenidone at a stable dose

Exclusion criteria:

  1. Any disease that may interfere with testing procedures or in judgement of investigator may interfere with trial participation or may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.31. However, patients may qualify for participation even though they meet the exclusion criteria (for 1199.31), if the investigators benefit-risk assessment remains favorable.
  2. Any other investigational therapy received within 8 weeks before visit 1.
  3. For female: Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for both at least 4 weeks prior to enrolment and 10 weeks after last study drug intake.

    For male: Sexually active males not committing to using condoms both during the course of the study and ten weeks after last study drug intake (except if their partner is not of childbearing potential).

  4. Known or suspected active alcohol or drug abuse.
  5. Patients who require full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, heparin), except low dose heparin and/or heparin flash as needed for maintenance of an indwelling intravenous device. As an example, prophylactic use of heparin, e.g. enoxaparin 2000 International unit (I.U.) subcutaneously (s.c.) per day, should be allowed.
  6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel) therapy. As an example, chronic low-dose acetyl salicylic acid, below or equal to 100 mg per day, should be allowed.
  7. 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01417156
Other Study ID Numbers  ICMJE 1199.40
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 January 2017

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