Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: BIBF 1120; BIBF 1120; BIBF 1120; BIBF 1120
Intervention description: Intermediate dose BIBF 1120 twice daily; High dose BIBF 1120 twice daily; Low dose BIBF 1120 twice daily; Low dose BIBF 1120 once daily
Intervention MeSH terms: Nintedanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.