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

Completed

• Conditions: Lung Diseases, Interstitial
• Interventions: Drug: Nintedanib

• Registration Number: NCT04559581
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-10-02
• Primary Completion: 2024-12-18
• Study Completion: 2025-01-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients newly initiating Nintedanib	Nintedanib	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions (ADRs)	up to 104 weeks

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.; 🇯🇵 Tokyo, Japan