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

Primary Purpose

Pulmonary Fibrosis

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Nintedanib

Pirfenidoneone

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Written informed consent consistent with Good Clinical Practice (GCP) signed prior to entry into the study
Completion of 1199.31 study and still under treatment with pirfenidone at a stable dose

Exclusion criteria:

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.
Any other investigational therapy received within 8 weeks before visit 1.
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).
Known or suspected active alcohol or drug abuse.
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.
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.
Patient not compliant in previous trial, with trial medication or trial visits.

Sites / Locations

Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site
Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Overall Adverse Events

Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.

Secondary Outcome Measures

Annual Rate of Decline in Forced Vital Capacity (FVC).

The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within-patient errors are modelled by an Unstructured variance-covariance matrix. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix. The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data.

Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height & random effect of patient specific intercept & time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance-covariance matrix. mmHg: millimeters of mercury

Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.

The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.

Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.

The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.

Full Information

NCT ID

NCT01417156

First Posted

August 15, 2011

Last Updated

January 13, 2017

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01417156

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All patients

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nintedanib

Intervention Description

150 mg bid

Intervention Type

Drug

Intervention Name(s)

Pirfenidoneone

Intervention Description

Existing treatment

Primary Outcome Measure Information:

Title

Incidence of Overall Adverse Events

Description

Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.

Time Frame

First drug administration until end of treatment, up to 5 years

Secondary Outcome Measure Information:

Title

Annual Rate of Decline in Forced Vital Capacity (FVC).

Description

Time Frame

Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years

Title

Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

Description

Time Frame

Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years

Title

Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.

Description

The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.

Time Frame

First drug administration until end of treatment, up to 5 years

Title

Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.

Description

The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.

Time Frame

Week 234

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Written informed consent consistent with Good Clinical Practice (GCP) signed prior to entry into the study Completion of 1199.31 study and still under treatment with pirfenidone at a stable dose Exclusion criteria: 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. Any other investigational therapy received within 8 weeks before visit 1. 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). Known or suspected active alcohol or drug abuse. 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. 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. Patient not compliant in previous trial, with trial medication or trial visits.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

Boehringer Ingelheim Investigational Site

City

Himeji, Hyogo

Country

Japan

Facility Name

Boehringer Ingelheim Investigational Site

City

Sakai, Osaka

Country

Japan

Facility Name

Boehringer Ingelheim Investigational Site

City

Seto, Aichi

Country

Japan

Facility Name

Boehringer Ingelheim Investigational Site

City

Yokohama, Kanagawa

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com

Description

Related Info

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

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