A PROSPECTIVE RANDOMIZED STUDY FOR THE DIAGNOSIS OF HUMAN CYTOMEGALOVIRUS (hCMV) INFECTION ACCORDING TO BASELINE hCMV-SPECIFIC T-CELL RESPONSE IN KIDNEY TRANSPLANT PATIENTS - RESPECT

HOSPITAL UNIVERSITARI DE BELLVITGE0 个研究点目标入组 160 人开始时间: 2016年5月10日最近更新: 2016年8月16日

试验速览

暂无简介。

•1. Subjects > 18 years old, both male and females, any race, with body weight >34 kg
•2. Subjects are hCMV positive and are due to receive a hCMV seropositive donor renal allograft
•3. Availability of receptor blood samples pre transplant to perform hCMV-specific ELISPOT determination.
•4. Subject is willing to participate in the study and has signed the Informed Consent Form. If a patient is unable to consent by writing, a legal representative is allowed to sign in his place.
•5. Women of Childbearing Potential must have a negative pregnancy test performed at the moment of inclusion and must accept the use of a reliable anticonceptive method during the lenght of the study
•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 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1. hCMV-specific ELISPOT test result indeterminate or lack of receptor blood sample to perform the test
•2. Subjects with a previously known tipe I hypersensibility or documented idiosyncratic reactions to ganciclovir(GCV)/valganciclovir(VGCV).
•3. Pregnant or lactating women.
•5. Any clinically significant disease that in the opinion of the investigator might interfere with the procedures of the trial
•6. Participation in another industry sponsored clinical trial that defines the treatment of CMV infection

发起方

HOSPITAL UNIVERSITARI DE BELLVITGE