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EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

NCT00105183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2012-06-11

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or lungs.

Conditions

Interventions

BIOLOGICAL

Placebo

placebo infusion, single

BIOLOGICAL

EZ-2053

single IV infusion, 9 mg/kg

BIOLOGICAL

EZ-2053 5mg/kg

single IV infusion, 5mg/kg

Sponsors & Collaborators

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Elbert P Trulock III, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • United States
  • Australia
  • Austria
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00105183 on ClinicalTrials.gov