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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Chungcheongbuk-do, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Chungcheongnam-do, Korea, Republic of, 31151
    • Soonchunhyang University Cheonan Hospital
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Hospital
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Gyeonggi-do, Korea, Republic of, 10380
    • Inje University Ilsan Paik Hospital
  • Gyeonggi-do, Korea, Republic of, 67924
    • Myongji Hospital
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Gyeongsangnam-do, Korea, Republic of, 51472
    • Gyeongsang National University Changwon Hospital
  • Jeju-do, Korea, Republic of, 63241
    • Jeju National University Hospital
  • Jeollabuk-do, Korea, Republic of, 54538
    • Wonkwang Univertisy Hospital
  • Jeollabuk-do, Korea, Republic of, 54907
    • Jeonbuk National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 02447
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of, 06591
    • Catholic University of Korea Seoul St. Mary's Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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))	Drug: Nintedanib; Nintedanib; Other Names: Ofev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Nintedanib
• Other Study ID Numbers: 1199-0417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No