The relationship of the pharmacokinetic parameters of ganciclovir with the efficacy and the patient safety

JRCT ID: jRCT1031210407

Registered date:02/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cytomegalovirus infection and disease
• Date of first enrollment: 10/11/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Multiple blood collection to measure blood levels of ganciclovir

Outcome(s)

• Primary Outcome: Relationship between area under the blood concentration time curve (AUC) and efficacy after administration of GCV

Secondary Outcome

Secondary endpoints for effectiveness
1.Relationship between trough concentration (Cmin) of GCV and efficacy
2.Relationship between maximum concentration (Cmax) of GCV and efficacy
3.Relationship between GCV AUC and efficacy under CHDF
4.Relationship between Cmin and efficacy CHDF
5.Relationship between Cmax and efficacy CHDF
Secondary endpoints for safety
1.Relationship between GCV AUC and "decrease in hemoglobin level"
2.Relationship between GCV AUC and "leukopenia"
3.Relationship between GCV AUC and "decrease in neutrophil count"
4.Relationship between GCV AUC and "platelet count reduction"
5.Relationship between GCV AUC and "ALT increase"
6.Relationship between GCV AUC and "ALP increase"
7.Relationship between GCV AUC and "AST increase"
8.Relationship between GCV AUC and "increased blood bilirubin"
9.Relationship between GCV AUC and "LDH increase"
10.Relationship between GCV AUC and "hypoalbuminemia"
11.Relationship between GCV AUC and "increased creatinine"
12.Relationship between GCV AUC and "decrease in creatinine clearance"
13-24.Relationship between Cmin and each laboratory data in 1-12 above
25-36.Relationship between Cmax and each laboratory data in 1-12 above
37-48.Relationship between AUC under CHDF and each laboratory data in 1-12 above
49-60.Relationship between Cmin under CHDF and each laboratory data in 1-12 above
61-72.Relationship between Cmax under CHDF and each laboratory data in 1-12 above
Exploratory endpoints
1.Search for factors that affect the AUC
2.Search for factors that affect Cmin
3.Search for factors that affect the Cmax
4.Search for GCV target AUC
5.Search for GCV target Cmin
6.Search for GCV target Cmax

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 criteria

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

Related Information

• Primary Sponsor: Sakaida Emiko
• Source(s) of Monetary Support: Chiba University Hospital