Chronic Obstructive PulmonaryPhase 3NCT00105183
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
A Phase 3 study testing EZ-2053 and EZ-2053 5mg/kg in people with Chronic Obstructive Pulmonary and Idiopathic Pulmonary Fibrosis, run by Neovii Biotech at 19 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis
- What is being tested?
- EZ-2053 and EZ-2053 5mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Jan 2005to Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States15 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospital & Clinics
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University
Nashville, Tennessee, 37232
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Texas Health Sciences Center
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Canada2 sites
University of Alberta
Edmonton, Alberta
Toronto General Hospital
Toronto
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis, Pulmonary Vascular Disease
- Being tested
- Placebo, EZ-2053, EZ-2053 5mg/kg
- Keywords
- pulmonary transplantation, Pulmonary Allograft Rejection
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Also called Saline
placebo infusion, single
EZ-2053Biological
Also called ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbit
single IV infusion, 9 mg/kg
EZ-2053 5mg/kgBiological
Also called ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbit
single IV infusion, 5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| EZ-2053 | Active comparator | Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053) Receives: Biological: EZ-2053 |
| Placebo | Placebo comparator | USP 0.9% sodium chloride solution Receives: Biological: Placebo |
| EZ-2053 5mg/kg | Active comparator | Anti-human-T-Lymphocyte Immune Globulin, Rabbit Receives: Biological: EZ-2053 5mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
Measured: 12 months
Secondary outcomes (8)
Number of Participants With Death or Graft Loss Post-transplant
Measured: 12 months
Number of Participants With Acute Rejection
Measured: 12 months
Number of Participants With Infections and Infestations
Measured: 12 months
Number of Participants With Severe Adverse Events
Measured: 12 months
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Measured: 12 months
Pulmonary Function Test, Forced Vital Capacity
Measured: 12 months
Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Measured: 12 months
Pulmonary Function Test, Forced Expiratory Flow 25-75
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elbert P Trulock III, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105183
- Sponsor's protocol ID
- EZ-2053-001
- Status last verified
- Jun 2012
- First submitted
- 8 Mar 2005
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00105183
- Acronym / sponsor ID
- EZ-2053-001
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis, Pulmonary Vascular Disease
- Keywords
- pulmonary transplantation, Pulmonary Allograft Rejection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Mar 2005 (estimated)
- Results
- Posted 8 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EZ-2053 | Active comparator | Biological: EZ-2053Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053) |
| Placebo | Placebo comparator | Biological: PlaceboUSP 0.9% sodium chloride solution |
| EZ-2053 5mg/kg | Active comparator | Biological: EZ-2053 5mg/kgAnti-human-T-Lymphocyte Immune Globulin, Rabbit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Salineplacebo infusion, single | Biological | Placebo |
| EZ-2053Also: ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbitsingle IV infusion, 9 mg/kg | Biological | EZ-2053 |
| EZ-2053 5mg/kgAlso: ATG, Anti-human-T-Lymphocyte Immune Globulin, Rabbitsingle IV infusion, 5mg/kg | Biological | EZ-2053 5mg/kg |
Primary outcome
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)
Time frame: 12 months
8 secondary outcomes
Number of Participants With Death or Graft Loss Post-transplant
Time frame: 12 months
Number of Participants With Acute Rejection
Time frame: 12 months
Number of Participants With Infections and Infestations
Time frame: 12 months
Number of Participants With Severe Adverse Events
Time frame: 12 months
Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test
Time frame: 12 months
Pulmonary Function Test, Forced Vital Capacity
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Volume in 1 Second
Time frame: 12 months
Pulmonary Function Test, Forced Expiratory Flow 25-75
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elbert P Trulock III, MD principal investigator
Washington University School of Medicine
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EZ-2053 and EZ-2053 5mg/kg in people with Chronic Obstructive Pulmonary and Idiopathic Pulmonary Fibrosis, run by Neovii Biotech at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, Australia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.