Status:
COMPLETED
Safety and Effectiveness of Nintedanib in Korean Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04525547
Start Date
January 13 2021
End Date
August 18 2022
Last Update
March 12 2024
Active Locations (22)
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1
Dong-A University Hospital
Busan, South Korea, 49201
2
Chungbuk national University Hospital
Chungcheongbuk-do, South Korea, 28644
3
SoonChunHyang University Cheonan Hospital
Chungcheongnam-do, South Korea, 31151
4
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601