All-Case Surveillance of Ofev in Patients With IPF in Japan

Overview

This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment. The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment. As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed). All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed. Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.

Full Title of Study: “The Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in Japan”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2, 2023

Interventions

  • Drug: Nintedanib

Arms, Groups and Cohorts

  • Nintedanib
    • Patients with IPF

Clinical Trial Outcome Measures

Primary Measures

  • The primary endpoint of this study is the frequency of patients with any suspected Adverse Drug Reactions (ADRs)
    • Time Frame: Week 104

Secondary Measures

  • The secondary endpoint of this study is absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 104
    • Time Frame: Week 104

Participating in This Clinical Trial

Inclusion Criteria

Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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