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OpenTrials
Completed

NCT Number: NCT04525547

Safety and Effectiveness of Nintedanib 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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Dong-A University Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nintedanib

Drug

Nintedanib

Other names: Ofev

Primary outcomes

  1. Number of Patients With Adverse Events Who Took at Least One Dose of Ofev

    Time frame: Up to 24 weeks.

    Number of patients with adverse events who took at least one dose of Ofev is presented.

  2. Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment

    Time frame: At baseline and at week 12.

    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.

  3. Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment

    Time frame: At baseline and at week 24.

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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