NCT00813618

Study of MEDI 507 in the Treatment of Pediatric Patients

Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.

Detailed description

This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and MEDI-507 for treatment of GvHD

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	MEDI-507	0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9
DRUG	MEDI-507	0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9
DRUG	MEDI-507	0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9

Timeline

• Start date: 1999-09-01
• Primary completion: 2004-06-01
• Completion: 2004-08-01
• First posted: 2008-12-23
• Last updated: 2008-12-23

Locations

6 sites across 1 country: United States