Safety and Effectiveness of Nintedanib in Korean Patients
A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients
1 other identifier
observational
70
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2022
CompletedResults Posted
Study results publicly available
March 12, 2024
CompletedMarch 12, 2024
August 1, 2023
1.6 years
August 21, 2020
August 14, 2023
August 14, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Study Arms (1)
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))
Interventions
Eligibility Criteria
* Patients diagnosed with idiopathic pulmonary fibrosis * (or) Patients diagnosed with systemic sclerosis associated interstitial lung disease * (or) patients diagnosed with chronic fibrosing ILD with a progressive phenotype
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Dong-A University Hospital
Busan, 49201, South Korea
Chungbuk national University Hospital
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
January 13, 2021
Primary Completion
August 2, 2022
Study Completion
August 18, 2022
Last Updated
March 12, 2024
Results First Posted
March 12, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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'.
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.