Single Arm Study to Assess the efficacy of UVADEX
Research type
Research Study
Full title
Single Arm Study to Assess the Efficacy of UVADEX (methoxsalen) Sterile Solution in conjunction with the Therakos CELLEX Photopheresis system in Pediatric Patients with steroid-refractory Acute Graft versus Host Disease (aGvHD)
IRAS ID
191668
Contact name
Andrew Gennery
Contact email
Sponsor organisation
Therakos
Eudract number
2014-004806-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
This is a single arm study to assess the efficacy of UVADEX® (methoxsalen) sterile solution in conjunction with the THERAKOS® Cellex® photopheresis system in Pediatric patients with steroid refractory Acute Graft Versus Host Disease (aGvHD). The study duration is 12 weeks. The primary objective is to evaluate the efficacy of extracorporeal photopheresis (ECP) in pediatric patients with steroid refractory aGvHD. The study will consist of Screening, Treatment and Follow up periods. Patients will be evaluated by the treating physician for the presence or absence of aGvHD manifestations of the skin, liver and gut. Extracorporeal photopheresis will be administered weeks 1-4 - 3 treatments per week and weeks 5-12 2 treatments per week. All adverse events will be recorded from the time the informed consent is signed until either the study completes or early cessation of treatment for whatever reason.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0483
Date of REC Opinion
23 Dec 2015
REC opinion
Further Information Favourable Opinion