drugset / Trial / NCT02524847

Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease

NCT02524847

Phase 3 Terminated 29 enrolled Therakos, Inc., a Mallinckrodt Company
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen) Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems (ECP) in pediatric participants with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and Follow-up Periods.

Timeline

Start
2016-01-20
Primary completion
2019-07-16
Completion
2019-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Methoxsalen Other / unclassified 20 ug/ml