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EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection

Information source: Neovii Biotech
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary; Idiopathic Pulmonary Fibrosis; Cystic Fibrosis; Bronchiectasis; Pulmonary Vascular Disease

Intervention: Placebo (Biological); EZ-2053 (Biological); EZ-2053 5mg/kg (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Neovii Biotech

Official(s) and/or principal investigator(s):
Elbert P Trulock III, MD, Principal Investigator, Affiliation: Washington University School of Medicine

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)

Secondary outcome:

Number of Participants With Death or Graft Loss Post-transplant

Number of Participants With Acute Rejection

Number of Participants With Infections and Infestations

Number of Participants With Severe Adverse Events

Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test

Pulmonary Function Test, Forced Vital Capacity

Pulmonary Function Test, Forced Expiratory Volume in 1 Second

Pulmonary Function Test, Forced Expiratory Flow 25-75

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Medical University of Vienna, Vienna, Austria

University of Alberta, Edmonton, Alberta, Canada

Toronto General Hospital, Toronto, Canada

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

University of California, San Francisco, San Francisco, California 94143, United States

Stanford University, Stanford, California 94305, United States

Mayo Clinic, Jacksonville, Florida 32224, United States

Emory University School of Medicine, Atlanta, Georgia 30322, United States

University of Iowa Hospital & Clinics, Iowa City, Iowa 52242, United States

University of Kentucky Medical Center, Lexington, Kentucky 40536, United States

Barnes-Jewish Hospital, St. Louis, Missouri 63110, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma 73112, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104, United States

Vanderbilt University, Nashville, Tennessee 37232, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Texas Health Sciences Center, San Antonio, Texas 78229, United States

The Alfred Hospital, Melbourne, Victoria, Australia

Additional Information

Starting date: January 2005
Last updated: June 7, 2012

Page last updated: August 20, 2015

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