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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01417156
First received: August 15, 2011
Last updated: January 13, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis Drug: Nintedanib Drug: Pirfenidoneone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients Drug: Nintedanib
150 mg bid
Drug: Pirfenidoneone
Existing treatment

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417156

Locations
Japan
Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan
Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01417156     History of Changes
Other Study ID Numbers: 1199.40
Study First Received: August 15, 2011
Results First Received: October 25, 2016
Last Updated: January 13, 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017