drugset / Trial / NCT05505409

Efficacy and Safety of Pirfenidone in CTD-ILD

NCT05505409

Phase 4 Unknown 120 enrolled Qilu Hospital of Shandong University
RandomizedParallel-groupOpen-labelTreatment

Summary

A single-center randomized controlled study will be used to observe the efficacy and safety of pirfenidone on CTD-ILD patients for 24 months. The main research endpoints is the lung function (FVC) at 6 months. The clinical dyspnea score, 6-minute walking distance, index of lung function and imaging indicators are evaluated, as well as primary disease activity and adverse reactions of therapy with glucocorticoid and immunosuppressants up to 24 months.

Timeline

Start
2022-06-22
Primary completion
2025-06-30
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirfenidone Small molecule