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

Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417156
• Other study ID #: 1199.40
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2011
• Last updated: November 30, 2015
• Start date: September 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• BIBF 1120

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence (number and % of patients) of overall adverse events		up to 5 years	Yes
Secondary	Time to first occurrence of Acute exacerbations of Idiopatic Pulmonary Fibrosis (IPF)		up to 5 years	No
Secondary	Forced Vital Capacity decline (mL/year)		From baseline up to 5 years	No
Secondary	Hemoglobin (Hb) corrected diffusing capacity for carbon monoxide (DLco) decline (mL/min/mmHg/year)		From baseline up to 5 years	No
Secondary	Number of acute exacerbations of Idiopathic Pulmonary Fibrosis (IPF) - per patient per year		up to 5 years	No