EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | March 8, 2005 | ||||
Last Updated Date | June 7, 2012 | ||||
Start Date ICMJE | January 2005 | ||||
Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Acute graft rejection or death at 6 months | ||||
Change History | Complete list of historical versions of study NCT00105183 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection | ||||
Official Title ICMJE | 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) | ||||
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. |
||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 223 | ||||
Completion Date | January 2011 | ||||
Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Australia, Austria, Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105183 | ||||
Other Study ID Numbers ICMJE | EZ-2053-001 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Fresenius Biotech GmbH | ||||
Study Sponsor ICMJE | Fresenius Biotech GmbH | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | Fresenius Biotech GmbH | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |