EUCTR2005-001131-30-AT进行中（未招募）不适用
A Double-Blind, Placebo-Controlled, Multicenter, Dose-ranging Study of an Anti-T-lymphocyte Immunglobuline (EZ-2053) in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s)
Fresenius Biotech North America0 个研究点目标入组 220 人开始时间: 2005年6月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- = 18 years of age
- •- 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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
- •- Undergoing second or living donor transplant
- •- Donor lung ischemia time >8 hours
- •- 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 weeks 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 = 2 times upper normal limit)
- •- 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 human immunodeficiency virus (HIV)
- •- Previous exposure or known contraindication to administration of EZ-2053 or rabbit proteins
- •- Current malignancy or a history of malignancy (within the previous 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully
- •- Unstable cardiovascular disease or 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 drug 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 or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator
- •Postoperatively, but prior to randomization, patients with any of the following will be excluded:
- •- Failure to document two measurements of PaO2/FiO2 >200mmHg, separated by 3 hours (+/- 1 hour), with the last measurement within 2 hours of randomization Note: for patients on a nasal cannula, estimate the FiO2 as 4% over 21% for each L/min. For example, 2 L/min = 21 %+ (2 x 4%) = 29%.
- •- Need for extracorporeal membrane oxygenation
- •- Uncontrolled bleeding
- •- Frank evidence of cardiopulmonary instability and/or a patient, who in the estimation of the transplant team, is at high risk for death
- •- Known positive blood culture (any pending microbiology tests should be reviewed prior to randomization)
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