Clinical Trials Logo
  1. Home
  2. Lung Diseases, Interstitial
  3. NCT04559581
  4. Details
NCT04559581 Clinical Trial

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

Lung Diseases, Interstitial Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04559581
Other study ID # 1199-0402
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 28, 2020
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 425
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nintedanib
Capsules

Locations
Country Name City State
Japan Nippon Boehringer Ingelheim Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions (ADRs) up to 104 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04119115 - Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
Recruiting NCT05151640 - INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Completed NCT02251964 - Rituximab in Interstitial Pneumonitis Phase 2/Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01442779 - Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT05866198 - Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation N/A
Active, not recruiting NCT05321082 - A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) Phase 3
Completed NCT04016168 - Idiopathic Pulmonary Fibrosis and Serum Bank
Recruiting NCT00258583 - Dorothy P. and Richard P. Simmons Center for ILD Research Registry
Recruiting NCT05855109 - Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
Completed NCT05719233 - Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Recruiting NCT04159129 - Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
Completed NCT03313180 - A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis Phase 3
Active, not recruiting NCT05065190 - A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis Phase 3
Completed NCT03136120 - Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
Recruiting NCT04930666 - BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Recruiting NCT05503030 - Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
Active, not recruiting NCT04702893 - 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

External Links