Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

• Register: EUCTR
• Last refreshed on: 18 April 2016
• Main ID: EUCTR2015-004441-17-Outside-EU/EEA
• Date of registration: 12/04/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
• Scientific title: A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection
• Target sample size: 74
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004441-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Panama, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
•History or laboratory evidence of herpes simplex infection
•Clinical evidence or suspicion of herpes simplex infection

Are the trial subjects under 18? yes
Number of subjects for this age range: 74
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:
•Patients unable to swallow
•Concomitant use of probenecid
•Positive pregnancy test



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

Health Condition(s) or Problem(s) studied

Herpes Simplex

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

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

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

Primary Outcome(s)

Main Objective: To evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.

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

Timepoint(s) of evaluation of this end point: 8 hours and 24 hours after study drug administration (Part A)

Secondary Objective: Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Day 1, after swallowing the dose. ] [ Designated as safety issue: No ]
Overall acceptability of the study medication was determined by caretaker response.

•Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Time Frame: Day 1 at clinic: after swallowing first dose ] [ Designated as safety issue: No ]
Overall acceptability of the study medication was determined by caretaker response.

•Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Time Frame: Day 8 at home: after swallowing last dose ] [ Designated as safety issue: No ]
Overall acceptability of study medication was determined by caretaker response.

Secondary Outcome(s)

Secondary end point(s): Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study

Timepoint(s) of evaluation of this end point: Day 1, after swallowing the dose

Secondary ID(s)

CFAM810B2303

NCT00098059

Source(s) of Monetary Support

Novartis Pharmaceuticals