Optimization of pre-emptive thrapy with valganciclovir based on TDM in treatment of cytomegalovirus

JRCT ID: jRCTs051240080

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients positive for cytomegalovirus pp65 antigen
• Date of first enrollment: 06/09/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Serum concentrations of ganciclovir is measured approximately once a week after initiation of valganciclovir. The clearance of individual patients is estimated by Bayesian method using a previously reported population pharmacokinetic model, and treatment dose is adjusted to achieve the target AUC (40-60 ug-hr/mL).

Outcome(s)

• Primary Outcome: To estimate the ratio of achievement of negative cytomegalovirus antigenemia within 3 weeks without serious adverse event for patients who conducted reemptive therapy with valganciclovir for cytomegalovirus reactivation

Secondary Outcome

1. Presence, type ,severity, and frequency of adverse event of oral valganciclovir
2. To estimete the difference in cytomegalovirus antigen levels at baseline and at weekly intervals after administration
3. To estimate the ratio of cytomegalovirus antigen levels to baseline at weekly intervals after the initiation of valganciclovir
4. Total dose of valganciclovir during pre-emptive therapy
5. Treatment period of valganciclovir for pre-emptive therapy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Inpatients at department of rheumatology and clinical immunology, Kobe University Hospital
2. Patients treated with prednisolone of more than or equal to 0.5 mg/kg with/without immunosuppressive agents as initial therapy
3. Patients aged 18 years or older at the time of consent acquisition
4. Patients for whom written informed consent has been obtained regarding their voluntary participation in this clinical study.
5. Patients who test positive for cytomegalovirus pp65 antigen and meet one of the following conditions
Cytomegalovirus pp65 antigen is more than or equal to 10 /2 slides
Cytomegalovirus pp65 antigen is more than or equal to 1/ 2 slides and less than or equal to 9 /2 slides, and retest result after 2 to 8 days was cytomegalovirus pp65 antigen is more than or equal to 5 /2 slides and higher than the initial value.
6. Patients without symptoms (e.g., fever, cough, dyspnea, abdominal pain, diarrhea, bloody stools, and dysopia) due to CMV infection
7. Patients who have not received VGCV at least 2 weeks before starting this clinical study

Exclude criteria

1. Patients with dialysis
2. Patients with significant bone marrow suppression such as neutrophil count less than 500 /mm3 or platelet count less than 25,000 /mm3
3. Pregnant women or women who may be pregnant
4. Patients with allergies or other drug sensitivities to the valganciclovir, ganciclovir, acyclovir, or valacyclovir.
5. Patients with hemoglobin levels less than 8.0 g/dL
6. Patients taking probenecid
7. Patients that the investigator deems inappropriate

Related Information

• Primary Sponsor: Saegusa Jun