Herpes Simplex Virus InfectionVALID2NCT04081480
Pharmacokinetics of Valacyclovir Oral Solution in Children
A study testing Valacyclovir in people with Herpes Simplex Virus Infection and Varicella Zoster Virus Infection, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Herpes Simplex Virus Infection, Varicella Zoster Virus Infection
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2019to 12 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is in the age of 2-12 years.
- Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
- Subject is managed with a central venous catheter (CVC/Port-a-Cath).
- 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.
Who cannot join
- Severe anemia (<6.0 mmol/L).
- Full dose has not been taken.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)
Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.
The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.
Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
- Being tested
- Valacyclovir
- Medical subject headings
- Herpes Simplex, Varicella Zoster Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir oral solution | Other | Valacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more. Receives: Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Acyclovir area under the curve (12h)
Measured: 12 hours
Cmax
Maximum concentration of aciclovir
Measured: 12 hours
Tmax
Time to reach maximum concentration of aciclovir
Measured: 12 hours
Secondary outcomes (1)
Number of adverse events
Number of adverse events
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start10 Dec 2019
- Primary completion12 May 2021
- Study completion12 May 2021
Why it stopped: Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Virus InfectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention is pharmacokinetic (PK) curve collection in children, two age groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081480
- Sponsor's protocol ID
- VALID2
- Acronym
- VALID2
- Status last verified
- Jun 2021
- First submitted
- 16 Jul 2019
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)
- ClinicalTrials.gov ID
- NCT04081480
- Acronym / sponsor ID
- VALID2 / VALID2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.
The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.
Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention is pharmacokinetic (PK) curve collection in children, two age groups
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir oral solution | Other | Drug: ValacyclovirValacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject is in the age of 2-12 years.
- Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
- Subject is managed with a central venous catheter (CVC/Port-a-Cath).
- 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.
Key exclusion criteria (2 listed)
- Severe anemia (<6.0 mmol/L).
- Full dose has not been taken.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValacyclovirPK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution | Drug | Valacyclovir oral solution |
Primary outcome
Area under the curve
Time frame: 12 hours
Acyclovir area under the curve (12h)
Cmax
Time frame: 12 hours
Maximum concentration of aciclovir
Tmax
Time frame: 12 hours
Time to reach maximum concentration of aciclovir
1 secondary outcome
Number of adverse events
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir in people with Herpes Simplex Virus Infection and Varicella Zoster Virus Infection, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed positive results, it was difficult to include patients and also the fact that the grant for this project has ended, we have decided to complete the study before we had included the total number of 16 patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (time frame: 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.