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EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00105183
Recruitment Status : Completed
First Posted : March 9, 2005
Results First Posted : June 8, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Idiopathic Pulmonary Fibrosis Cystic Fibrosis Bronchiectasis Pulmonary Vascular Disease Biological: Placebo Biological: EZ-2053 Biological: EZ-2053 5mg/kg Phase 3

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-surgical assessment consisting of medical history, physical exam, ECG, chest X-Ray, and blood tests are conducted. After lung transplant surgery, patients are assessed for continued eligibility. Within 6-24 hours after the end of surgery, patients are randomized to receive one infusion of study drug or placebo through a central venous catheter. Each day for 5 days following transplant surgery, patients are monitored for transplant rejection, infections, adverse events and laboratory test changes. On post-randomization Days 14, 30, 60, 90, 180, 270 and 365, patients will be monitored for acute transplant rejection, infections and cancer, pulmonary function tests and adverse experiences. Pulmonary biopsies will be performed on post-randomization Days 30, 60, 90, 180 and 365. Blood samples will be drawn during each visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)
Study Start Date : January 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2011


Arm Intervention/treatment
Active Comparator: EZ-2053
Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
Biological: EZ-2053
single IV infusion, 9 mg/kg
Other Names:
  • ATG
  • Anti-human-T-Lymphocyte Immune Globulin, Rabbit

Placebo Comparator: Placebo
USP 0.9% sodium chloride solution
Biological: Placebo
placebo infusion, single
Other Name: Saline

Active Comparator: EZ-2053 5mg/kg
Anti-human-T-Lymphocyte Immune Globulin, Rabbit
Biological: EZ-2053 5mg/kg
single IV infusion, 5mg/kg
Other Names:
  • ATG
  • Anti-human-T-Lymphocyte Immune Globulin, Rabbit




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of Participants With Death or Graft Loss Post-transplant [ Time Frame: 12 months ]
  2. Number of Participants With Acute Rejection [ Time Frame: 12 months ]
  3. Number of Participants With Infections and Infestations [ Time Frame: 12 months ]
  4. Number of Participants With Severe Adverse Events [ Time Frame: 12 months ]
  5. Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test [ Time Frame: 12 months ]
  6. Pulmonary Function Test, Forced Vital Capacity [ Time Frame: 12 months ]
  7. Pulmonary Function Test, Forced Expiratory Volume in 1 Second [ Time Frame: 12 months ]
  8. Pulmonary Function Test, Forced Expiratory Flow 25-75 [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105183


Locations
Show Show 19 study locations
Sponsors and Collaborators
Neovii Biotech
Investigators
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Principal Investigator: Elbert P Trulock III, MD Washington University School of Medicine
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Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00105183    
Other Study ID Numbers: EZ-2053-001
First Posted: March 9, 2005    Key Record Dates
Results First Posted: June 8, 2012
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Neovii Biotech:
pulmonary transplantation
Pulmonary Allograft Rejection
Additional relevant MeSH terms:
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Cystic Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bronchiectasis
Vascular Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Cardiovascular Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Bronchial Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents