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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)

NCT00806208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2008-12-11

No results posted yet for this study

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.

Conditions

  • Graft-Versus-Host Disease

Interventions

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • J. Bruce McClain, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2000-01-31
Completion
2000-03-31

Countries

  • United States

Study Locations

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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 NCT00806208 on ClinicalTrials.gov