NCT00806208

Trial for Evaluation of Safety of Escalating Dose Levels of MEDI-507 in Patients for Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II Graft-Versus-Host Disease (GvHD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.

Detailed description

The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.

Conditions

• Graft-Versus-Host Disease

Interventions

Type	Name	Description
DRUG	MEDI-507	0.012 mg/kg MEDI 507 and Methylprednisolone
DRUG	MEDI-507	0.04 mg/kg MEDI 507 and Methylprednisolone
DRUG	MEDI-507	0.12 mg/kg MEDI 507 and Methylprednisolone
DRUG	MEDI-507	0.4 mg/kg MEDI 507 and Methylprednisolone
OTHER	Placebo	Placebo IV (alternative) study days 0, 3,6, and 9

Timeline

• Start date: 1999-01-01
• Primary completion: 2000-01-01
• Completion: 2000-03-01
• First posted: 2008-12-10
• Last updated: 2008-12-11

Locations

3 sites across 1 country: United States