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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 October 2017
Main ID:  NCT00105183
Date of registration: 08/03/2005
Prospective Registration: Yes
Primary sponsor: Neovii Biotech
Public title: EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Scientific title: 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)
Date of first enrolment: January 2005
Target sample size: 223
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia Austria Canada United States
Name:     Elbert P Trulock III, MD
Affiliation:  Washington University School of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Undergoing second or living donor transplant

- Prior treatment with T-cell depleting agents within the previous 5 years for the
purpose of immunosuppression

- Prior plasma exchange and/or treatment with IVIg within the past 5 years

- Pulmonary infection with pan-resistant Pseudomonas or any Burkholderia species

- Known positive blood cultures

- Donor lung ischemia time > 8 hours for first lung and > 8 hours for the second lung

- Previously received or is receiving a multi-organ transplant

- Pregnant women, nursing mothers or women of child-bearing potential who are unwilling
to use reliable contraception. Effective contraception must be used BEFORE beginning
study drug therapy, for the duration of the study and for 6 months following
completion of the study

- Active, extra-pulmonary systemic infection requiring the prolonged or chronic use of
antimicrobial agents or the presence of a chronic active hepatitis B or C

- Active liver disease (liver function tests greater than or equal to 2 times the upper
limit of normal)

- Severe anemia (hemoglobin, < 6 g/dL), leukopenia (WBC < 2500/mm3), thrombocytopenia
(platelet count < 80,000/mm3), polycythemia (Hct > 54% [male], Hct > 49% [female]) or
clinically significant coagulopathy

- Recipient or donor is seropositive for HIV

- Previous exposure or known contraindication to administration of the study drug or to
rabbit proteins

- Current malignancy or a history of malignancy (within the previous 5 years), except
non-metastatic basal cell or squamous cell carcinoma of the skin or carcinoma in-situ
of the cervix that has been treated successfully

- Unstable cardiovascular disease, or a myocardial infarction within the previous 6

- Currently participating in another clinical trial with an investigational agent and/or
is taking or has been taking an investigational agent in the 30 days prior to
transplant and/or has not recovered from any reversible side effects of prior
investigational drug

- Unlikely to comply with visits schedule in the protocol

- Any current history of substance abuse, psychiatric disorder or a condition that, in
the opinion of the Investigator, may invalidate communication with the Investigator.

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Obstructive Pulmonary
Cystic Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Vascular Disease
Biological: EZ-2053
Biological: EZ-2053 5mg/kg
Biological: Placebo
Primary Outcome(s)
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) [Time Frame: 12 months]
Secondary Outcome(s)
Number of Participants With Acute Rejection [Time Frame: 12 months]
Number of Participants With Death or Graft Loss Post-transplant [Time Frame: 12 months]
Number of Participants With Infections and Infestations [Time Frame: 12 months]
Number of Participants With Severe Adverse Events [Time Frame: 12 months]
Pulmonary Function Test, Forced Expiratory Flow 25-75 [Time Frame: 12 months]
Pulmonary Function Test, Forced Expiratory Volume in 1 Second [Time Frame: 12 months]
Pulmonary Function Test, Forced Vital Capacity [Time Frame: 12 months]
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test [Time Frame: 12 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 08/06/2012
Date Completed:
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