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

Phase 2

Completed

• Conditions: Pulmonary Fibrosis
• Interventions: Drug: Nintedanib; Drug: Pirfenidoneone

• Registration Number: NCT01417156
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Study Start: 2011-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-10-25
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Nintedanib	-
All patients	Pirfenidoneone	-

Primary Outcome Measures

Name	Time	Method
Incidence of Overall Adverse Events	First drug administration until end of treatment, up to 5 years	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

Name	Time	Method
Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.	First drug administration until end of treatment, up to 5 years	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.
Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years	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
Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.	Week 234	The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.
Annual Rate of Decline in Forced Vital Capacity (FVC).	Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years	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.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan