Safety and pharmacokinetics of valganciclovir syrup formulation in paediatric solid organ transplant recipients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 63

Inclusion Criteria

1.parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study
2.patient has received a first solid organ transplant (e.g. liver, kidney, heart etc)
3.males or females aged between 3 months and 16 years
4.patient at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV)
5.patient has adequate haematological and renal function as defined as:
a.Absolute neutrophil count (ANC) > 1300 cells/µL
b.Platelet count > 40,000 cells/µL
c.Haemoglobin > 8.0 g/dL
d.Estimated renal function of > 35 mL/min/1.73m2 (not applicable for kidney transplants)
6.patient is able to tolerate oral medication (NG tube accepted unless patient expected to be dependant on NG tube beyond 1 week)
7.negative pregnancy test (blood or urine) for females of child bearing potential before initiation of valganciclovir treatment
8.patients of reproductive potential agree to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 for liver transplant patients)
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objectives : <br>1)To describe the safety and tolerability profile of valganciclovir syrup and tablets in paediatric solid organ transplant recipients<br>;Secondary Objective: Secondary objectives : <br>2)To determine the pharmacokinetics of ganciclovir following oral administration of valganciclovir syrup and tablets in paediatric solid organ transplant recipients<br>3)To describe the incidence of CMV disease (including genotyping of UL97 and UL54 loci as appropriate)<br>;Primary end point(s): To describe the safety and tolerability profile of valganciclovir syrup and tablets in paediatric solid organ transplant recipients

Secondary Outcome Measures

Name	Time	Method

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