drugset / Trial / NCT02958917

Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis

NCT02958917

Phase 2 Terminated 40 enrolled Evans Fernandez Perez Genentech, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. These antigens can be substances such as molds, chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into the bloodstream to reach other organs. Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your condition. The use of pirfenidone has not been approved for the treatment of FHP. It is considered experimental treatment in this study.

Timeline

Start
2017-06-05
Primary completion
2021-03-02
Completion
2021-03-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pirfenidone Small molecule 2403 mg Oral