Trials / Completed
CompletedNCT00105183
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- Neovii Biotech · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Patients are generally consented for the study once they go on the lung transplant waiting list and then are re-consented periodically thereafter until they undergo the lung transplant surgery. A pre-surgical assessment consisting of medical history, physical exam, ECG, chest X-Ray, and blood tests are conducted. After lung transplant surgery, patients are assessed for continued eligibility. Within 6-24 hours after the end of surgery, patients are randomized to receive one infusion of study drug or placebo through a central venous catheter. Each day for 5 days following transplant surgery, patients are monitored for transplant rejection, infections, adverse events and laboratory test changes. On post-randomization Days 14, 30, 60, 90, 180, 270 and 365, patients will be monitored for acute transplant rejection, infections and cancer, pulmonary function tests and adverse experiences. Pulmonary biopsies will be performed on post-randomization Days 30, 60, 90, 180 and 365. Blood samples will be drawn during each visit.
Conditions
- Chronic Obstructive Pulmonary
- Idiopathic Pulmonary Fibrosis
- Cystic Fibrosis
- Bronchiectasis
- Pulmonary Vascular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | placebo infusion, single |
| BIOLOGICAL | EZ-2053 | single IV infusion, 9 mg/kg |
| BIOLOGICAL | EZ-2053 5mg/kg | single IV infusion, 5mg/kg |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2010-01-01
- Completion
- 2011-01-01
- First posted
- 2005-03-09
- Last updated
- 2012-06-11
- Results posted
- 2012-06-08
Locations
19 sites across 4 countries: United States, Australia, Austria, Canada
Source: ClinicalTrials.gov record NCT00105183. Inclusion in this directory is not an endorsement.