Research on the improvement of ease of use and product safety of T-Track® CMV kit - CMVextend, LB-D1

ophius Biosciences GmbH0 个研究点目标入组 49 人开始时间: 2016年6月9日最近更新: 2024年8月19日

适应症

试验速览

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•healthy individuals:
•- written informed consent,
•- male or female at least 18 years of age
•- 100 CMV-seropositive probands
•- 50 CMV-seronegative probands
•additional criteria for patients receiving a kidney graft:
•- patient has received a kidney graft
•- patient is CMV-seropositive
•additional criteria for patients receiving a bone-marrow transplant:
•- allogeneic hematopoietic stem cell transplantation at least 3 months before blood collection
•- patient is CMV-seropositive at the time of blood collection

•healthy individuals:
•- acute infectious diseases
•- test person is known to be positive for HBV, HCV or HIV infection
•- any form of alcohol or substance abuse
•- hemodynamic instability
•- any form of psychiatric disorder
•- defect of innate / adaptive immune system
•additional criteria for patients receiving a kidney graft:
•- patients receiving ATG at time of blood withdrawal or within a period of 30 days prior to blood withdrawal
•- patient has significant uncontrolled concomitant infections or other unstable medical conditions that, in the opinion of the investigator may indicate that the patient is ineligible for blood withdrawal
•additional criteria for patients receiving a bone marrow transplant:
•- patients receiving haploidentical allogeneic hematopoietic stem cell graft
•- patients receiving Alemtuzumab at time of blood withdrawal or within a period of 30 days prior to blood withdrawal

发起方

ophius Biosciences GmbH