Phase 3
N=223
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Chronic Obstructive Pulmonary · Idiopathic Pulmonary Fibrosis · Cystic Fibrosis · Bronchiectasis · Pulmonary Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00105183 ↗Enrolled (actual)
223
Serious AEs
72.9%
Results posted
Jun 2012
Primary outcome: Primary: Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) — 33; 29; 30 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Biological); EZ-2053 (Biological); EZ-2053 5mg/kg (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neovii Biotech
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) |
33; 29; 30 | — |
| SECONDARY Number of Participants With Death or Graft Loss Post-transplant |
13; 8; 7 | — |
| SECONDARY Number of Participants With Acute Rejection |
22; 20; 22 | — |
| SECONDARY Number of Participants With Infections and Infestations |
75; 70; 57 | — |
| SECONDARY Number of Participants With Severe Adverse Events |
18; 14; 9 | — |
| SECONDARY Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test |
457.0; 448.0; 427.0 | — |
| SECONDARY Pulmonary Function Test, Forced Vital Capacity |
3.0; 2.9; 3.3 | — |
| SECONDARY Pulmonary Function Test, Forced Expiratory Volume in 1 Second |
2.3; 2.3; 2.5 | — |
| SECONDARY Pulmonary Function Test, Forced Expiratory Flow 25-75 |
2.7; 2.2; 2.6 | — |
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.
Eligibility 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, 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.
Data sourced from ClinicalTrials.gov (NCT00105183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.