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Active Not RecruitingNCT04325217

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
586 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.

Conditions

Interventions

TypeNameDescription
DRUGNintedanibCapsules

Timeline

Start date
2020-05-27
Primary completion
2026-06-30
Completion
2026-06-30
First posted
2020-03-27
Last updated
2026-03-17

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT04325217. Inclusion in this directory is not an endorsement.

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disea (NCT04325217) · Clinical Trials Directory