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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525547
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : August 8, 2022
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
Actual Enrollment : 70 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
Actual Study Start Date : January 13, 2021
Actual Primary Completion Date : August 2, 2022
Actual Study Completion Date : August 2, 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 ]
  2. Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12, 24 weeks of treatment [ Time Frame: at baseline, at week 12, at 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 chronic fibrosing ILD with a progressive phenotype
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


Locations
Show Show 22 study locations
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: August 8, 2022
Last Verified: August 2022
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://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.

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://www.mystudywindow.com/msw/datasharing

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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
Nintedanib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action