Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04559581
Collaborator
(none)
440
1
51.1
8.6
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
440 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Actual Study Start Date
:
Sep 28, 2020
Anticipated Primary Completion Date
:
Sep 30, 2024
Anticipated Study Completion Date
:
Dec 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients newly initiating Nintedanib
|
Drug: Nintedanib
Capsules
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse drug reactions (ADRs) [up to 104 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | Japan | 1416017 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04559581
Other Study ID Numbers:
- 1199-0402
First Posted:
Sep 23, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: