| DEC-NET Serial number ES599 |
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| Published online | 23/10/2006 16.13.00 |
| Last updated | 23/10/2006 16.12.43 |
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| Other protocol ID number | WV16726 |
| Current trial status | Complete(closed to recruitment of participants: follow-up complete) |
Major Disease
(ICD9 class) | CYTOMEGALOVIRAL DISEASE |
| Experimental drug |
Valganciclovir
Treatment regimen (dosage and duration)
N/A |
| Gender | Both |
| Age (range) | From 3 moths to 16 years of age |
Eligibility criteria |
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| Exclusion criteria |
| Patients with any of the following will be excluded from the study:
1. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past.
2. Patient has severe, uncontrolled diarrhea (more than 5 watery stools per day).
3. Patient has liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT). (not applicable to liver or heart transplant recipients).
4. Patient requires use of any protocol prohibited concomitant medications.
5. Patient has previously participated in this clinical trial.
6. Patient is a lactating female who will not discontinue nursing prior to study entry.
7. Patient is simultaneously participating in another clinical trial except as approved by the Sponsor. |
Trial design/methodology |
| Phase | 2 |
| Kind of study | Safety
Pharmacokinetics |
| Design | |
| Purpose of study |
| - To describe the safety and tolerability profile of valganciclovir syrup and tablets in pediatric solid organ transplant recipients.
- To determine the pharmacokinetics of ganciclovir following oral administration of valganciclovir syrup and tablets in pediatric solid organ transplant recipients.
- To describe the incidence of CMV disease (including genotyping of UL97 and UL54 loci as appropriate). |
| Primary outcomes |
| - Safety
Endpoints referring to:
(1) adverse events and opportunistic infections (including CMV);
(2) chages of dose due to adverse events;
and (3) abnormal blood or biochemical plasma values.
- Pharmacokinetics
AUC
Cmax
half life
clearance
bioavailability
Values of safety vs AUC.
cambios adversos en los valores de hematología y bioquímica sanguínea.
Farmacocinética:
AUC
Cmáx
semivida
aclaramiento sistémico biodisponibilidad
Valores de seguridad frente a AUC. |
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| Summary of study design, objectives, and ongoing research findings |
| The safety and efficacy of ganciclovir and its pro-drug valganciclovir is well established in adults for treatment and prevention of CMV disease; however there are limited data in children. Liquid formulations of valganciclovir have been developed to determine a suitable and convenient dosing regimen for children across a range of renal function. Two pharmacokinetic studies (WP16296 and WP16303) have been performed to aid dosing recommendations in this patient population. A dosing algorithm was developed from the results of these studies which can be used to calculate doses to deliver similar exposure to all ages of children as that found to be safe and effective in adults.
This study has been set up to assess the safety, tolerability and pharmacokinetics of ganciclovir, from valganciclovir syrup and tablets during prophylaxis, in pediatric patients receiving solid organ transplants, using a dosing algorithm based on estimated creatinine clearance (CrCL )and body surface area.
The scheduled number of patients have been included in the study. First data of this study will be presented in the World Transplant Congress in Boston (USA) on July 2006. |
