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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00105183
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00105183