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

NCT04325217 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 586

Last updated 2026-03-17

No results posted yet for this study

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

  • Lung Diseases, Interstitial

Interventions

DRUG

Nintedanib

Capsules

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325217 on ClinicalTrials.gov