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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01417156
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Fibrosis
Interventions Drug: Nintedanib
Drug: Pirfenidoneone
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nintedanib
Hide Arm/Group Description Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Period Title: Overall Study
Started 20
Completed 6
Not Completed 14
Reason Not Completed
Adverse Event             12
Protocol Violation             2
Arm/Group Title Nintedanib
Hide Arm/Group Description Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Treated set (TS): This analysis set included all patients who were given study medication and were documented to have taken at least one dose of the trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
65.8  (9.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
1.Primary Outcome
Title Incidence of Overall Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS)
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
AEs leading to discontinuation of trial drug 12
Fatal 8
Severe AEs 11
2.Secondary Outcome
Title Annual Rate of Decline in Forced Vital Capacity (FVC).
Hide Description

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.

Time Frame Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
TS-OC Observed Case (OC): This method was used for the replacement of missing values.
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Participants Analyzed 20
Least Squares Mean (Standard Error)
Unit of Measure: (mililitre (mL)/year)
-233.3  (72.59)
3.Secondary Outcome
Title Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Hide Description

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

Time Frame Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
OC-TS
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Participants Analyzed 20
Mean (Standard Error)
Unit of Measure: mL/Minute(min)/mmHg per year
-1.3  (0.26)
4.Secondary Outcome
Title Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: patients per 100 patient-year
19.2
(8.29 to 37.82)
5.Secondary Outcome
Title Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nintedanib
Hide Arm/Group Description:
Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
Failure (Week 234) 40.0
Censored (Week 234) 60.0
Time Frame First drug administration until end of treatment, up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nintedanib
Hide Arm/Group Description Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
All-Cause Mortality
Nintedanib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Nintedanib
Affected / at Risk (%)
Total   16/20 (80.00%) 
Cardiac disorders   
Acute myocardial infarction  1  1/20 (5.00%) 
Right ventricular failure  1  1/20 (5.00%) 
Gastrointestinal disorders   
Anal fistula  1  1/20 (5.00%) 
Constipation  1  1/20 (5.00%) 
General disorders   
Asthenia  1  1/20 (5.00%) 
Pyrexia  1  1/20 (5.00%) 
Hepatobiliary disorders   
Cholecystitis  1  2/20 (10.00%) 
Infections and infestations   
Appendicitis  1  1/20 (5.00%) 
Herpes zoster  1  1/20 (5.00%) 
Oral candidiasis  1  1/20 (5.00%) 
Pneumonia  1  2/20 (10.00%) 
Respiratory tract infection  1  2/20 (10.00%) 
Tuberculosis  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders   
Tendonitis  1  1/20 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma of lung  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/20 (5.00%) 
Dyspnoea exertional  1  4/20 (20.00%) 
Hypoxia  1  1/20 (5.00%) 
Idiopathic pulmonary fibrosis  1  13/20 (65.00%) 
Pneumothorax  1  2/20 (10.00%) 
Vascular disorders   
Deep vein thrombosis  1  2/20 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nintedanib
Affected / at Risk (%)
Total   19/20 (95.00%) 
Blood and lymphatic system disorders   
Anaemia  1  2/20 (10.00%) 
Gastrointestinal disorders   
Abdominal discomfort  1  2/20 (10.00%) 
Abdominal pain  1  4/20 (20.00%) 
Abdominal pain upper  1  2/20 (10.00%) 
Constipation  1  8/20 (40.00%) 
Dental caries  1  2/20 (10.00%) 
Diarrhoea  1  13/20 (65.00%) 
Gastritis  1  2/20 (10.00%) 
Haemorrhoids  1  3/20 (15.00%) 
Nausea  1  12/20 (60.00%) 
Vomiting  1  5/20 (25.00%) 
General disorders   
Chest pain  1  2/20 (10.00%) 
Oedema peripheral  1  2/20 (10.00%) 
Pyrexia  1  3/20 (15.00%) 
Infections and infestations   
Bronchitis  1  2/20 (10.00%) 
Nasopharyngitis  1  7/20 (35.00%) 
Oral candidiasis  1  3/20 (15.00%) 
Pharyngitis  1  2/20 (10.00%) 
Pneumonia  1  2/20 (10.00%) 
Investigations   
Hepatic enzyme increased  1  3/20 (15.00%) 
Weight decreased  1  5/20 (25.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  7/20 (35.00%) 
Hyperkalaemia  1  2/20 (10.00%) 
Hypokalaemia  1  2/20 (10.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/20 (15.00%) 
Nervous system disorders   
Dysgeusia  1  3/20 (15.00%) 
Headache  1  2/20 (10.00%) 
Psychiatric disorders   
Insomnia  1  4/20 (20.00%) 
Renal and urinary disorders   
Haematuria  1  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Haemoptysis  1  2/20 (10.00%) 
Upper respiratory tract inflammation  1  2/20 (10.00%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  2/20 (10.00%) 
Eczema  1  2/20 (10.00%) 
Pruritus  1  2/20 (10.00%) 
Vascular disorders   
Hypertension  1  6/20 (30.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Annual ROD in FVC results to be interpreted with caution & along with descriptive statistics as inferences used might not be valid as suggested by skewed distribution of data thus Absolute Change from baseline in FVC over time has been defined.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01417156    
Other Study ID Numbers: 1199.40
First Submitted: August 15, 2011
First Posted: August 16, 2011
Results First Submitted: October 25, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017