EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis, Pulmonary Vascular Disease

In brief

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.

Key facts

Study ID

NCT00105183

Run by

Neovii Biotech

People needed

223

Starts

2005-01-01

Expected to finish

2011-01-01

Last updated by the study team

2012-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Iowa Hospital & Clinics — Iowa City, Iowa, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• INTEGRIS Baptist Medical Center — Oklahoma City, Oklahoma, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Sciences Center — San Antonio, Texas, United States
• The Alfred Hospital — Melbourne, Victoria, Australia
• Medical University of Vienna — Vienna, Austria
• University of Alberta — Edmonton, Alberta, Canada
• Toronto General Hospital — Toronto, Canada

Full record on ClinicalTrials.gov

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