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Clinical Trials/EUCTR2017-001451-30-NL
EUCTR2017-001451-30-NL
Active, not recruiting
Phase 1

Pharmacokinetics of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase II (VALID II) - VALID-2

Radboud university medical center0 sites16 target enrollmentMay 13, 2019
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ConditionsHerpes virus infections, especially Herpes Simplex and Varicella Zoster.MedDRA version: 20.0Level: PTClassification code 10019973Term: Herpes virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsZelitrex

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Herpes virus infections, especially Herpes Simplex and Varicella Zoster.
Sponsor
Radboud university medical center
Enrollment
16
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 13, 2019
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subject is in the age of 1\-12 years.
  • •2\.Subject has an indication for (val)acyclovir prophylaxis and receives i.v. acyclovir.
  • •3\.Subject is managed with a central venous catheter (CVC/Port\-a\-Cath).
  • •4\.Subject’s parents have signed the Informed Consent Form prior to screening evaluations.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 16
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Severe anemia (Hb \< 5\.0 mmol/L).
  • •2\.Full dose has not been taken.

Outcomes

Primary Outcomes

Not specified

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