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

Phase 2

Recruiting

• Conditions: Cytomegalovirus infection and disease

• Registration Number: JPRN-jRCT1031210407
• Lead Sponsor: Sakaida Emiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between area under the blood concentration time curve (AUC) and efficacy after administration of GCV