Safety and Effectiveness of Nintedanib in Korean Patients
- Registration Number
- NCT04525547
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Patients who have been started on Ofev in accordance with the approved label in Korea
- Patients who have signed on the data release consent form
-
Patients for whom nintedanib is contraindicated according local label of Ofev
- Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients
- Women who are pregnant or nursing
- Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ofev treatment Nintedanib 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))
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events Who Took at Least One Dose of Ofev Up to 24 weeks. Number of patients with adverse events who took at least one dose of Ofev is presented.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment At baseline and at week 12. 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.Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment At baseline and at week 24. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
SoonChunHyang University Cheonan Hospital
🇰🇷Chungcheongnam-do, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Myongji Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Chungbuk national University Hospital
🇰🇷Chungcheongbuk-do, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju-do, Korea, Republic of
Wonkwang Univertisy Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
KyungHee University Medical Center
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of