CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 223 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
EZ-2053 9 mg/kg single IV infusionAI-extracted
Key inclusion· 2
  • ✓Recipient of a primary single or double pulmonary allograft
  • ✓Capable of understanding study purposes and risks, with written informed consent and agreement to comply
Key exclusion· 16
  • ✕Undergoing second or living donor transplant
  • ✕Prior T-cell depleting agents within 5 years for immunosuppression
  • ✕Prior plasma exchange and/or IVIg within 5 years
  • ✕Pulmonary infection with pan-resistant Pseudomonas or any Burkholderia species

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00105183
NCT00105183Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of an Anti-human-T-lymphocyte Immune Globulin (EZ-2053) in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s)

Neovii Biotech·interventional·Posted Mar 9, 2005·Updated Jun 11, 2012

In Brief

A Phase 3 clinical trial evaluating Placebo, EZ-2053, and 1 other intervention for Chronic Obstructive Pulmonary and 4 related conditions. Completed, enrolled 223 participants across 19 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis, Pulmonary Vascular Disease
CountriesAustralia, Austria, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2005
Enrollment StartJan 1, 2005
Primary CompletionJan 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 21.3 years ago

Interventions

Placebobiological

placebo infusion, single

EZ-2053biological

single IV infusion, 9 mg/kg

EZ-2053 5mg/kgbiological

single IV infusion, 5mg/kg