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The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofev treatment | Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID)) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Nintedanib |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events Who Took at Least One Dose of Ofev | Number of patients with adverse events who took at least one dose of Ofev is presented. | Up to 24 weeks. |
| Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment | Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation. | At baseline and at week 12. |
| Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment | Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation. | At baseline and at week 24. |
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Inclusion Criteria:
Exclusion Criteria:
Patients for whom nintedanib is contraindicated according local label of Ofev
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | 49201 | South Korea | |||
| Chungbuk national University Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
The objective of this non-interventional, multi-center study was to monitor the safety profile and effectiveness of Ofev in Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype in routine clinical settings based on new collected data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofev Treatment | Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID)) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2022 | Jul 6, 2023 |
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| Chungcheongbuk-do |
| 28644 |
| South Korea |
| SoonChunHyang University Cheonan Hospital | Chungcheongnam-do | 31151 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Inje University Ilsan Paik Hospital | Gyeonggi-do | 10380 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Myongji Hospital | Gyeonggi-do | 67924 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gyeongsang National University Changwon Hospital | Gyeongsangnam-do | 51472 | South Korea |
| Jeju National University Hospital | Jeju-do | 63241 | South Korea |
| Wonkwang Univertisy Hospital | Jeollabuk-do | 54538 | South Korea |
| Jeonbuk National University Hospital | Jeollabuk-do | 54907 | South Korea |
| KyungHee University Medical Center | Seoul | 02447 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Hanyang University Medical Center | Seoul | 04763 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Catholic University of Korea Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ofev Treatment | Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID)) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Forced Vital Capacity (FVC) at baseline | The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. | Mean | Standard Deviation | MilliLitres (mL) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events Who Took at Least One Dose of Ofev | Number of patients with adverse events who took at least one dose of Ofev is presented. | The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 24 weeks. |
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| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment | Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation. | The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. Only participants with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | MilliLitres (mL) | At baseline and at week 12. |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment | Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation. | The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. Only participants with non-missing results were included in the analysis. | Posted | Mean | Standard Deviation | MilliLitres (mL) | At baseline and at week 24. |
|
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Up to 24 weeks.
The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ofev Treatment | Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID)) | 3 | 65 | 16 | 65 | 17 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2019 | Jul 6, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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