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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-02

Study Completion Date

2025-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis

NCT07080125

Interstitial Lung Diseases Systemic Sclerosis Associated Interstitial Lung Disease

ACTIVE_NOT_RECRUITING

A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

NCT03958071

Idiopathic Pulmonary Fibrosis

COMPLETED

INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation

NCT04702893

Lung Diseases, Interstitial

COMPLETED

Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients

NCT05503030

Lung Diseases, Interstitial

TERMINATED

Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

NCT02594059

Pulmonary Fibrosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Diseases, Interstitial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients newly initiating Nintedanib

Nintedanib

Intervention Type DRUG

Capsules

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nintedanib

Capsules

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ofev

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No