Safety and Effectiveness of Nintedanib in Korean Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525547
• Other study ID #: 1199-0417
• Status: Completed
• Start date: January 13, 2021
• Est. completion date: August 18, 2022

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 18, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Nintedanib
Nintedanib

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Chungbuk national University Hospital	Chungcheongbuk-do
Korea, Republic of	SoonChunHyang University Cheonan Hospital	Chungcheongnam-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Gyeonggi-do
Korea, Republic of	Myongji Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gyeongsang National University Changwon Hospital	Gyeongsangnam-do
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Jeju National University Hospital	Jeju-do
Korea, Republic of	Jeonbuk National University Hospital	Jeollabuk-do
Korea, Republic of	Wonkwang Univertisy Hospital	Jeollabuk-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 24 weeks.
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.	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.	At baseline and at week 24.

External Links

•   Related Info