solid organ transplants
Conditions
Interventions
Product Name: Valcyte
Product Code: Ro 107-9070
Pharmaceutical Form: Powder for syrup
INN or Proposed INN: Valganciclovir
Current Sponsor code: Ro 107-9070
Concentration unit: mg/ml milligram(s)/milli
Sponsors
Roche Products Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objectives : 1) To describe the safety and tolerability profile of valganciclovir syrup and tablets in paediatric solid organ transplant recipients ;Secondary Objective: Secondary objectives : 2) To determine the pharmacokinetics of ganciclovir following oral administration of valganciclovir syrup and tablets in paediatric solid organ transplant recipients 3) To describe the incidence of CMV disease (including genotyping of UL97 and UL54 loci as appropriate) ;Primary end point(s): To describe the safety and tolerability profile of valganciclovir syrup and tablets in paediatric solid organ transplant recipients | — |
Countries
Spain, United Kingdom
Outcome results
None listed