Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032292
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2002-03-14
Brief Title:
Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
Sponsor:
Facet Biotech
Organization:
Facet Biotech
Study Overview
Official Title:
A Phase III Open-Label Dose-Escalation Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this Phase III open-label dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute Grade II III or IV graft-versus-host disease GVHD Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment The research is being conducted at up to 10 clinical research sites in the US
Detailed Description:
A Phase III open-label dose-escalation pilot study designed to obtain preliminary safety pharmacokinetic PK and efficacy information on visilizumab administered as a first-line therapy to patients with acute Grade II III or IV graft-versus-host disease GVHD It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment 2 mgkg of methylprednisolone IV or 10 mgkg hydrocortisone IV per day Steroids will be rapidly tapered over one week following visilizumab administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None