Clinical trial NCT04525547: Safety and Effectiveness of Nintedanib in Korean Patients
Official title: A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-08-25
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

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 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

Primary outcomes:
measure: Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
timeFrame: Up to 24 weeks.
measure: Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
timeFrame: At baseline and at week 12.
measure: Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
timeFrame: At baseline and at week 24.
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Chungbuk national University Hospital
city: Chungcheongnam-do
country: Korea, Republic of
facility: SoonChunHyang University Cheonan Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Jeju-do
country: Korea, Republic of
facility: Jeju National University Hospital
city: Jeollabuk-do
country: Korea, Republic of
facility: Wonkwang Univertisy Hospital
city: Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References: