Clinical trial

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

Name

1199-0402

Description

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).

Trial arms

Trial start

2020-09-28

Estimated PCD

2024-09-30

Trial end

2024-12-31

Status

Active (not recruiting)

Treatment

Nintedanib

Capsules

Arms:

Patients newly initiating Nintedanib

Other names:

Ofev

Size

425

Primary endpoint

Incidence of adverse drug reactions (ADRs)

up to 104 weeks

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 425, 'type': 'ACTUAL'}}

Updated at

2023-07-12

1 organization

1 product

2 indications

Product

Indication

Indication

Organization