A monocentre, randomised, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (cytomegalovirus [CMV], adenovirus [ADV], herpes simplex virus [HSV]) specific T-cells in addition to determination of trough levels of immunosuppressants in paediatric kidney and liver allograft recipients: an explorative study

Medical School of Hannover (MHH) (Germany)0 个研究点目标入组 64 人开始时间: 2009年6月17日最近更新: 2021年3月1日

适应症

试验速览

•1. Patients who are males or non-pregnant females between the ages of 0 and 16 years
•2. Patients after kidney or liver transplantation
•3. Patients who receive their first or second transplantation
•4. Patients who are single-organ recipients
•5. If patients are women of childbearing potential, they must have a negative serum pregnancy test with a sensitivity equal to at least 50 mIU/ml before transplantation
•6. If patients are women of childbearing potential, they must use two reliable forms of contraception simultaneously unless abstinence is the chosen method. Effective contraception must be used before transplantation, during therapy, and for 6 weeks following discontinuation of immunosuppressive therapy.
•7. Patients' guardians must be capable of understanding the purpose and risks of the study
•8. Patients whose guardians are willing to give written informed consent and willing to participate in and comply with the study protocol. Patients above 7 years have to agree with the study in addition to the informed consent of the legally authorised representative.

•1. Patients participating in other studies or participated within the last four weeks
•2. Patients who are highly sensitised
•3. Patients who have previously undergone two organ transplantations
•4. Hypersensitivity to any of the components of the medication used
•5. Patients from other centres, who are not followed in the outpatient unit of the Hannover Medical School
•6. Patients with a peak or current panel-reactive antibodies (PRA) of greater than 50%
•7. Pregnant and/or lactating women and women of childbearing potential who are unwilling or unable to use contraception methods as specified
•8. Patients whose guardians do not understand the requirements of the study
•9. Patients with known positive human immunodeficiency virus-1 (HIV-1) or hepatitis C virus (HCV) test or the presence of hepatitis B surface antigen (HBsAg)
•10. Patients with malignancies or history of malignancy, despite post-transplant lymphoproliferative disease
•11. Patients who are not eligible in the opinion of the physician
•12. Significant medical history and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient?s safety, compliance, or study evaluations, according to the investigator's opinion

发起方

Medical School of Hannover (MHH) (Germany)