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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01417156
First received: August 15, 2011
Last updated: August 6, 2014
Last verified: August 2014
  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: BIBF 1120
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

Secondary Outcome Measures:
  • Time to first occurrence of Acute exacerbations of Idiopatic Pulmonary Fibrosis (IPF) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Forced Vital Capacity decline (mL/year) [ Time Frame: From baseline up to 5 years ] [ Designated as safety issue: No ]
  • Hemoglobin (Hb) corrected diffusing capacity for carbon monoxide (DLco) decline (mL/min/mmHg/year) [ Time Frame: From baseline up to 5 years ] [ Designated as safety issue: No ]
  • Number of acute exacerbations of Idiopathic Pulmonary Fibrosis (IPF) - per patient per year [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 Drug: BIBF 1120

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
1199.40.008 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan
1199.40.007 Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan
1199.40.005 Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan
1199.40.003 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01417156     History of Changes
Other Study ID Numbers: 1199.40
Study First Received: August 15, 2011
Last Updated: August 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014