Status:
COMPLETED
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Lead Sponsor:
Neovii Biotech
Conditions:
Chronic Obstructive Pulmonary
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 reje...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00105183
Start Date
January 1 2005
End Date
January 1 2011
Last Update
June 11 2012
Active Locations (19)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Mayo Clinic
Jacksonville, Florida, United States, 32224