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

INTERVENTION: Product Name: Anti‐T‐lymphocyte Immune Globulin Product Code: EZ‐2053 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: EZ‐2053 Other descriptive name: Anti‐T‐lymphocyte Immune globuline Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐mg Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Patients with end‐stage pulmonary failure, who are receiving a primary single or double pulmonary allograft PRIMARY OUTCOME: Main Objective: The objective of this study is to assess the efficacy and safety of EZ‐2053 9 mg/kg as compared to placebo for prophylaxis of acute pulmonary allograft rejection in adult recipients of a primary pulmonary allograft. Primary end point(s): Efficacy failure between placebo and 9 mg/kg EZ‐2053 at 12 months post‐transplant. Efficacy failure is defined as the first occurrence of death, graft loss, acute rejection (as defined in Section 10.1) and/or loss to follow‐up. Secondary Objective: . INCLUSION CRITERIA: ‐ = 18 years of age ‐ Recipient of a primary single or double pulmonary allograft ‐ Capable of understanding the purposes and risks of the study and has given written informed consent, and agrees to comply with the study requirements ‐ Women of childbearing potential must have a negative serum pregnancy test within 4 days prior to randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range