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Safety and Effectiveness of Nintedanib in Korean Patients

NCT ID: NCT04525547

Last Updated: 2024-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-13

Study Completion Date

2022-08-18

Brief Summary

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

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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))

Nintedanib

Intervention Type DRUG

Nintedanib

Interventions

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Nintedanib

Nintedanib

Intervention Type DRUG

Other Intervention Names

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Ofev

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dong-A University Hospital

Busan, , South Korea

Site Status

Chungbuk national University Hospital

Chungcheongbuk-do, , South Korea

Site Status

SoonChunHyang University Cheonan Hospital

Chungcheongnam-do, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Inje University Ilsan Paik Hospital

Gyeonggi-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Myongji Hospital

Gyeonggi-do, , South Korea

Site Status

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status

Gyeongsang National University Changwon Hospital

Gyeongsangnam-do, , South Korea

Site Status

Jeju National University Hospital

Jeju-do, , South Korea

Site Status

Wonkwang Univertisy Hospital

Jeollabuk-do, , South Korea

Site Status

Jeonbuk National University Hospital

Jeollabuk-do, , South Korea

Site Status

KyungHee University Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Hanyang University Medical Center

Seoul, , South Korea

Site Status

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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1199-0417

Identifier Type: -

Identifier Source: org_study_id

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