Pharmacokinetic testing of a new paediatric formulation of valacyclovir.
Phase 1
- Conditions
- Herpes 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]
- Registration Number
- EUCTR2017-001451-30-NL
- Lead Sponsor
- Radboud university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method