Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

Boehringer Ingelheim

Status: Completed

Conditions: Lung Diseases, Interstitial

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT04559581

EUPAS36605 (Registry Identifier)

1199-0402

Details and patient eligibility

About

The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).

Enrollment: 425 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Exclusion criteria

• Diagnosis of Idiopathic Pulmonary Fibrosis
• Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease

Trial design

425 participants in 1 patient group

Ofev Capsules

Description:

Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.

Treatment:

Drug: Nintedanib