Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Intervention: Nintedanib; Pirfenidoneone
Intervention description: 150 mg bid; Existing treatment
Intervention MeSH terms: Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility 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.