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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00105183




Registration number
NCT00105183
Ethics application status
Date submitted
8/03/2005
Date registered
9/03/2005
Date last updated
11/06/2012

Titles & IDs
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)
Secondary ID [1] 0 0
EZ-2053-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary 0 0
Idiopathic Pulmonary Fibrosis 0 0
Cystic Fibrosis 0 0
Bronchiectasis 0 0
Pulmonary Vascular Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo
Treatment: Other - EZ-2053
Treatment: Other - EZ-2053 5mg/kg

Active comparator: EZ-2053 - Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)

Placebo comparator: Placebo - USP 0.9% sodium chloride solution

Active comparator: EZ-2053 5mg/kg - Anti-human-T-Lymphocyte Immune Globulin, Rabbit


Treatment: Other: Placebo
placebo infusion, single

Treatment: Other: EZ-2053
single IV infusion, 9 mg/kg

Treatment: Other: EZ-2053 5mg/kg
single IV infusion, 5mg/kg
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Number of Participants With Death or Graft Loss Post-transplant
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Number of Participants With Acute Rejection
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Number of Participants With Infections and Infestations
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Number of Participants With Severe Adverse Events
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Pulmonary Function Test, Forced Vital Capacity
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Pulmonary Function Test, Forced Expiratory Flow 25-75
Timepoint [8] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 months
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
223
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Vienna
Country [13] 0 0
Canada
State/province [13] 0 0
Edmonton, Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neovii Biotech
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elbert P Trulock III, MD
Address 0 0
Washington University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00105183