Safety and Effectiveness of Nintedanib in Korean Patients

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT04525547

1199-0417

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Ofev treatment

Description:

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))

Treatment:

Drug: Nintedanib