|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
2 December 2024 |
|
Main ID: |
NCT04325217 |
|
Date of registration:
|
26/03/2020 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
|
|
Scientific title:
|
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan |
|
Date of first enrolment:
|
May 27, 2020 |
|
Target sample size:
|
586 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT04325217 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never
been treated with Ofev Capsules before enrolment will be included.
Exclusion Criteria:
- None.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Lung Diseases, Interstitial
|
|
Intervention(s)
|
|
Drug: Nintedanib
|
|
Primary Outcome(s)
|
|
Incidence of adverse drug reactions (ADRs)
[Time Frame: up to 3 years and 9 months]
|
|
Secondary ID(s)
|
|
1199-0387
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|