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

NCT04559581 | Completed Results

• 2 other identifiers: 1199-0402EUPAS36605
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Nintedanib DRUG

Ofev Capsules as prescribed by the treating physician

Also known as: Ofev

Ofev Capsules

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Location

Related Publications (1)

• Ito T, Shibuya A, Noguchi H. Safety and Tolerability of Nintedanib in Japanese Patients with Progressive Fibrosing Interstitial Lung Diseases: Final Results of 2-Year Post-Marketing Surveillance. Adv Ther. 2026 Feb 20. doi: 10.1007/s12325-026-03502-w. Online ahead of print.

  PMID: 41718945 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Due to the nature of a single cohort observational study, there are issues that may impose limitations, in particular on the validity of the assessment based on the study data, such as selection bias, loss to follow up, channeling bias, and information and recall bias. Thus, comparisons and causal conclusions cannot be made, except for the investigator reported drug-related adverse events.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: October 2, 2020
• Primary Completion: December 18, 2024
• Study Completion: January 22, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

JP (1)