A multicenter, open-label, single-arm study to evaluate the single-dose pharmacokinetics, acceptability and safety of famciclovir oral pediatric formulation in infants 1 month to <1 year of age with herpes simplex or varicella zoster virus infections

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-005010-12-DE
• Date of registration: 15/01/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A multicenter, open-label, single-arm study to evaluate the single-dose pharmacokinetics, acceptability and safety of famciclovir oral pediatric formulation in infants 1 month to <1 year of age with herpes simplex or varicella zoster virus infections
• Scientific title: A multicenter, open-label, single-arm study to evaluate the single-dose pharmacokinetics, acceptability and safety of famciclovir oral pediatric formulation in infants 1 month to <1 year of age with herpes simplex or varicella zoster virus infections
• Date of first enrolment: 02/04/2007
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005010-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male and female patients from 1 month to <1 year of age, regardless of their immune status, who have active, suspected or latent herpes simplex infection, who are at risk of developing herpes simplex virus infections, and who are candidates for antiviral therapy.

2. Patients may be starting or currently using acyclovir. Patients on oral, i.v. or topical antiviral therapy (acyclovir, valacyclovir, ganciclovir) ideally should have a wash-out period of =8 hours prior to study drug administration. The investigator will carefully assess the impact of discontinuing standard therapy before enrollment. If the investigator feels that discontinuation of current antiviral is not indicated, then the patient may be enrolled without a washout period. Patients who require episodic antiviral treatment (acyclovir or valacyclovir) should be given their final dose =8 hours prior to dosing.

3. Patients expected to survive more than 4 weeks.
4. Patients whose physical examination demonstrates no abnormalities that would make this study medically hazardous to them.
5. Patients with Informed Consent Forms [approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)] signed by the parent/legal guardians
6. Patients whose parent/guardians are able to follow verbal and/or written instructions in the local language.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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. Patients with a gestational age <32 weeks. Patients with a gestational age <35 weeks are excluded from Cohort 1 only.
2. Patients unable to swallow (patients who are unconscious/coma due to encephalitis, patients who have extensive gingivo-stomatitis are excluded only if drinking is impaired)
3. Patients with a history of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could effect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion.
4. Patients with a clinically significant abnormality of the hepatic and renal systems.
5. Patients with any of the following age-adjusted clinical or hematological laboratory and blood chemistry abnormalities (Grade 2 abnormalities as defined by ranges of the local laboratory. The following values are given as guidances):
- AST/SGOT or ALT/SGPT greater than 3x ULN
- Total bilirubin greater than 2x ULN
- Serum creatinine greater than 2x ULN
- Absolute WBC count less than 4000 /mm3
- Platelet counts less than 50 000 /mm.
- Hemoglobin < 7.0 g/dL
6. Patients with a known hypersensitivity to famciclovir or penciclovir or drugs with similar chemical structures.
7. Patients concomitantly using probenecid
8. Patients who sustained a significant blood volume loss (>3% of calculated blood volume) in the past 30 days.
9. Patients who have taken an investigational drug or participated in an investigational study (with the exceptions of protocols studying marketed nucleoside analogues for herpes infections) within 30 days or 5 half-lives (which ever is longer) prior to study drug administration.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

herpes simplex or varicella zoster virus infections in infants 1 month to <1 year of age
MedDRA version: 8.1 Level: LLT Classification code 10019948 Term: Herpes simplex

Intervention(s)

Product Name: Famciclovir sprinkle capsules
Product Code: FAM810B
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Famciclovir
CAS Number: 104227-87-4
Current Sponsor code: FAM810
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: Famciclovir sprinkle capsules
Product Code: FAM810B
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Famciclovir
CAS Number: 104227-87-4
Current Sponsor code: FAM810
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To evaluate the pharmacokinetics of a single dose of famciclovir in infants 1 month to <1 year of age who are at risk of, or who have herpes simplex virus infections.

Secondary Objective: • To assess the safety of the single dose of famciclovir; and
• To assess tolerability/acceptability of the pediatric formulation.

Primary end point(s): Pharmacokinetics, safety and tolerability/acceptability

Secondary ID(s)

CFAM810B2301