A single-arm phase II study of the relationship of the pharmacokinetic parameters of ganciclovir with the efficacy and the patient safety in the treatment of cytomegalovirus infection

Sakaida Emiko0 个研究点目标入组 80 人开始时间: 2021年11月2日最近更新: 2023年10月17日

适应症

试验速览

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•Patients who receive GCV injection in normal treatment, and who fall under all of 1 to 5 or all of 1 to 6
•1)Age 20 years or older
•2)Patients diagnosed as CMV positive in any of the following
•a)The number of pp65 antigen (C7-HRP)-positive polymorphonuclear leukocytes in the CMV antigen test is 2/50,000 or more.
•b)The number of pp65 antigen (C10/C11) positive polymorphonuclear leukocytes in the CMV antigen test is 3 or more in total for 2 slides.
•3)Inpatients in the Department of Hematology, Allergy and Clinical Immunology, Emergency and Critical Care Medicine, General Surgery, Hepato-Biliary-Pancreatic Unit, Esophageal-Gastro-Intestinal Surgery, General Thoracic Surgery, or Respiratory Medicine
•4)Patients who receive GCV injection for CMV infection or disease. With or without history of treatment with GCV injections
•5)Able to consent this study by oneself or proxies and provide written informed consent
•6)Patients undergoing continuous hemodiafiltration (CHDF). Patients undergoing CHDF intermittently

•Exclude patients who fall under any of the following
•1)Patients with a history of hypersensitivity to the components of GCV injection, valganciclovir, acyclovir, and valacyclovir
•2)Pregnant women or women who may be pregnant
•3)Dialysis patients. Patients undergoing CHDF and patients undergoing CHDF intermittently are included in the study
•4)Patients who have already participated in this study
•5)Considered ineligible for other reasons

发起方

Sakaida Emiko