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

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).

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial
• Intervention / Treatment: Drug: Nintedanib

• Study Type: Observational
• Enrollment (Actual): 425

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1416017
    • Nippon Boehringer Ingelheim Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Non-interventional study in patients in Japan with chronic fibrosing ILDs with the progressive phenotype who are prescribed with Ofev and have never been treated with Ofev before; except patients with a diagnosis of idiopathic pulmonary fibrosis or patients with other chronic fibrosing ILDs with the progressive phenotype due to systemic sclerosis as the underlying disease. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ofev Capsules; 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.	Drug: Nintedanib; Ofev Capsules as prescribed by the treating physician; Other Names: Ofev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Drug Reactions (ADRs)	Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'.	From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; nintedanib
• Other Study ID Numbers: 1199-0402; EUPAS36605 (Registry Identifier: HMA-EMA Catalogues of real-world data sources and studies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No