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Status:

COMPLETED

Safety and PK Study of BIBF 1120 in Japanese Patients With IPF

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Idiopathic Pulmonary Fibrosis

Eligibility:

All Genders

40+ years

Phase:

PHASE2

Brief Summary

To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment. To assess pharmacokinetics of BIBF 1120 in Japanes...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
  • Forced vital capacity (FVC) 50-90%
  • Diffusing capacity for carbon monoxide (DLCO) 30-79%
  • For patients on pirfenidone, have been on a steady dose for at least 3 months
  • Exclusion criteria:
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 1.5 x upper limit of normal range (ULN) at screening.
  • Bilirubin \> 1.5 x ULN at screening.
  • Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC \<0.7) at screening.
  • Continuous oxygen supplementation.
  • Active infection at screening or randomisation.
  • Being treated with any of the following concomitant medications.
  • Oral corticosteroid medication at unstable dose
  • ketoconazole or atazanavir
  • Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening

Exclusion

    Key Trial Info

    Start Date :

    May 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT01136174

    Start Date

    May 1 2010

    Last Update

    January 6 2015

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    1199.31.002 Boehringer Ingelheim Investigational Site

    Bunkyo-ku,Tokyo, Japan

    2

    1199.31.004 Boehringer Ingelheim Investigational Site

    Hamamatsu, Shizuoka, Japan

    3

    1199.31.008 Boehringer Ingelheim Investigational Site

    Himeji, Hyogo, Japan

    4

    1199.31.006 Boehringer Ingelheim Investigational Site

    Nagoya, Aichi, Japan