MedTrace Logo

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

NCT02524847 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-09-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Steroid Refractory Acute Graft Versus Host Disease

Interventions

DRUG

Methoxsalen

Sterile solution used in conjunction with photopheresis procedure.

PROCEDURE

Extracorporeal Photopheresis (ECP)

Sponsors & Collaborators

  • Therakos, Inc., a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-20
Primary Completion
2019-07-16
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT02524847 on ClinicalTrials.gov