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Safety and Effectiveness of Nintedanib in Korean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525547
Recruitment Status : Not yet recruiting
First Posted : August 25, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Drug: Nintedanib

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022


Group/Cohort Intervention/treatment
Patients treated with Nintedanib Drug: Nintedanib
Nintedanib
Other Name: Ofev




Primary Outcome Measures :
  1. Number of adverse events in patients who take at least one dose of Ofev [ Time Frame: up to 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Forced Vital Capacity) (FVC)(mL) after 24 weeks of treatment [ Time Frame: baseline and week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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 Progressive Fibrosing Interstitial Lung Disease(PF-ILD)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525547


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 61469
Contact: Hong-Joon Shin    82-62-220-6919    99naussica@naver.com   
Asan Medical Center
Seoul, Korea, Republic of, 05505
Contact: Jinwoo Song    82-2-3010-3993    jwsong@amc.seoul.kr   
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Contact: Man Pyo Chung    82-2-3410-3423    mpchung@skku.edu   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04525547    
Other Study ID Numbers: 1199-0417
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html 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 http://trials.boehringer-ingelheim.com/ 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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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'.
URL: https://trials.boehringer-ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action