Clinical Trial Results:
Pharmacokinetics of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase II (VALID II)
Summary
|
|
EudraCT number |
2017-001451-30 |
Trial protocol |
NL |
Global end of trial date |
12 May 2021
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Aug 2024
|
First version publication date |
24 Aug 2024
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
UMCN-AKF12.07
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Radboud university medical center
|
||
Sponsor organisation address |
Geert grooteplein Zuid 10, Nijmegen, Netherlands, 6525GA
|
||
Public contact |
David Burger, Radboud university medical center, 31 243616405, david.burger@radboudumc.nl
|
||
Scientific contact |
David Burger, Radboud university medical center, 31 243616405, david.burger@radboudumc.nl
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
06 Aug 2024
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
12 May 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
12 May 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
To investigate the pharmacokinetics of valacyclovir oral so-lution in children who have received stem cell transplanta-tion (plasma) by determining the AUC0-12, time above Ccrit, Cmax and Tmax of acyclovir and comparing them with Ccrit (0.18 mg/L)and AUCcrit24 (4.3 mg*h/L).
|
||
Protection of trial subjects |
Subject’s parents have signed the Informed Consent Form prior to screening evaluations.
Subject is willing to participate after study procedures are explained in comprehensible language for the child.
A subject may decide to withdraw from the trial at any time. If so, the investigator must be informed immediately. The investigator may decide to terminate participation of a sub-ject if it is difficult to obtain blood samples, if there has been a violation of the protocol, if a serious adverse event occurs, or if it is in the best interest of the subject that he/she is withdrawn. If there is a medical reason for withdrawal, the subject will remain under the care of the investigator until the problem prompting withdrawal has been resolved or until referral to his general practitioner. On the basis of the occurrence of adverse events, the investigator may decide to discontinue the trial.
Data are collected pseudonymised.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Sep 2019
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Netherlands: 7
|
||
Worldwide total number of subjects |
7
|
||
EEA total number of subjects |
7
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
7
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||
Recruitment
|
|||||||
Recruitment details |
Seven patients (4 boys, 3 girls) were included in the Princes Maxima Centre in Utrecht, The Netherlands. Five patients in the range of 1-6 years old and two patients in the range of 7-12 years old. All seven patients received a stemcell transplantation and therefore used prophylactic valacyclovir. | ||||||
Pre-assignment
|
|||||||
Screening details |
Subjects must meet the following criteria to be eligible for participation in this trial: 1. Subject is in the age of 1-12 years. 2. Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution. 3. Subject is managed with a central venous catheter (CVC/Port-a-Cath). | ||||||
Period 1
|
|||||||
Period 1 title |
screening (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not applicable
|
||||||
Arms
|
|||||||
Arm title
|
valacyclovir | ||||||
Arm description |
Subjects will receive the following medication (according to standard of care): - Valacyclovir oral solution 20 mg/mL FNA (national standard formulation) Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM. | ||||||
Arm type |
standard of care | ||||||
Investigational medicinal product name |
valacyclovir
|
||||||
Investigational medicinal product code |
|||||||
Other name |
|||||||
Pharmaceutical forms |
Oral solution
|
||||||
Routes of administration |
Oral use
|
||||||
Dosage and administration details |
Valacyclovir oral solution 20 mg/mL FNA (national standard formulation)
Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM.
|
||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
screening
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
valacyclovir
|
||
Reporting group description |
Subjects will receive the following medication (according to standard of care): - Valacyclovir oral solution 20 mg/mL FNA (national standard formulation) Patients < 40 kg will receive 10 mg/kg and patients > 40 kg will receive 500 mg (25 mL) valacylcovir as oral solution at approximately 8 AM. |
|
|||||||||
End point title |
AUC [1] | ||||||||
End point description |
|||||||||
End point type |
Primary
|
||||||||
End point timeframe |
over 12 hours
|
||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descirptive satistics were done |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
% above Crit AUC (4.3) | ||||||
End point description |
|||||||
End point type |
Secondary
|
||||||
End point timeframe |
24 hours
|
||||||
|
|||||||
No statistical analyses for this end point |
|
|||
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
entire study
|
||
Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
|
|||
Dictionary name |
none | ||
Dictionary version |
0
|
||
Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events were reported |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
20 Apr 2015 |
1 Including children with a Hb between 5 and 6 mmol/L
The children who already use valacyclovir oral solution appeared to have in some cases a Hb below 6 mmol/L. Since these children belong to the population who will use this oral solu-tion, inclusion of these children will be valuable. The amount of blood that will be taken is al-ready low, maximum om 25 ml in total. The percentage blood taken, will never be more than 5%. According to the WHO Bulletin on blood sample volume in child health research, the effect on Hb is minimal if the total amount of blood loss is below 5%.
2 Including children between one and two years old
The oral solution of valacyclovir is already used in children between one and two years old. When considering the pharmacokinetics of valacyclovir in children in between this age, there is barely any difference between children between one and two years old and children be-tween two and five years old. Therefore it will be valuable to include these children in this study.
|
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
this study did not fully recruit |