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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

Group Type EXPERIMENTAL

Nintedanib

Intervention Type DRUG

150 mg bid

Pirfenidoneone

Intervention Type DRUG

Existing treatment

Interventions

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Nintedanib

150 mg bid

Intervention Type DRUG

Pirfenidoneone

Existing treatment

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No