Trial Outcomes & Findings for Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) (NCT NCT01417156)
NCT ID: NCT01417156
Last Updated: 2017-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
First drug administration until end of treatment, up to 5 years
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
Nintedanib
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.
|
|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Nintedanib
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.
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|---|---|
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Overall Study
Adverse Event
|
12
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)
Baseline characteristics by cohort
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
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Gender
Male
|
14 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: First drug administration until end of treatment, up to 5 yearsPopulation: Treated set (TS)
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.
Outcome measures
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Incidence of Overall Adverse Events
AEs leading to discontinuation of trial drug
|
12 participants
|
|
Incidence of Overall Adverse Events
Fatal
|
8 participants
|
|
Incidence of Overall Adverse Events
Severe AEs
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline and every 8 weeks after drug administration until end of treatment, up to 5 yearsPopulation: TS-OC Observed Case (OC): This method was used for the replacement of missing values.
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.
Outcome measures
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Annual Rate of Decline in Forced Vital Capacity (FVC).
|
-233.3 (mililitre (mL)/year)
Standard Error 72.59
|
SECONDARY outcome
Timeframe: Baseline & every 8 weeks after drug administration until end of treatment, up to 5 yearsPopulation: OC-TS
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
Outcome measures
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
|
-1.3 mL/Minute(min)/mmHg per year
Standard Error 0.26
|
SECONDARY outcome
Timeframe: First drug administration until end of treatment, up to 5 yearsPopulation: TS
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.
Outcome measures
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.
|
19.2 patients per 100 patient-year
Interval 8.29 to 37.82
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SECONDARY outcome
Timeframe: Week 234Population: TS
The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.
Outcome measures
| Measure |
Nintedanib
n=20 Participants
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.
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|---|---|
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Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.
Failure (Week 234)
|
40.0 percentage of participants
|
|
Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.
Censored (Week 234)
|
60.0 percentage of participants
|
Adverse Events
Nintedanib
Serious events: 16 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nintedanib
n=20 participants at risk
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.
|
|---|---|
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Cardiac disorders
Acute myocardial infarction
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Cardiac disorders
Right ventricular failure
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Anal fistula
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
General disorders
Asthenia
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
General disorders
Pyrexia
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Appendicitis
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Respiratory tract infection
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Tuberculosis
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
4/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
65.0%
13/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
Other adverse events
| Measure |
Nintedanib
n=20 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
65.0%
13/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
60.0%
12/20 • First drug administration until end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • First drug administration until end of treatment, up to 5 years
|
|
General disorders
Chest pain
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
General disorders
Pyrexia
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Nasopharyngitis
|
35.0%
7/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Oral candidiasis
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Pharyngitis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Investigations
Hepatic enzyme increased
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Investigations
Weight decreased
|
25.0%
5/20 • First drug administration until end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.0%
7/20 • First drug administration until end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • First drug administration until end of treatment, up to 5 years
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
4/20 • First drug administration until end of treatment, up to 5 years
|
|
Renal and urinary disorders
Haematuria
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • First drug administration until end of treatment, up to 5 years
|
|
Vascular disorders
Hypertension
|
30.0%
6/20 • First drug administration until end of treatment, up to 5 years
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER