Clinical Trial Results:
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 varicella zoster infection
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Summary
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EudraCT number |
2015-004442-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
30 Jul 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2016
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First version publication date |
19 Dec 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CFAM810B2304
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00098046 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH 4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jul 2007
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jul 2007
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the trial was:
Part A:
To evaluate the safety and tolerability, and pharmacokinetics (PK) of a single dose of famciclovir oral pediatric formulation in children from 1 to 12 years of age with varicella zoster virus (VZV) infection, in order to define the dose in this age group which gives a similar exposure to famciclovir 500 mg dose in adults
Part B:
To explore the safety and tolerability of multiple doses of famciclovir administered three times-daily over 7 days in children from 1 to 12 years of age who had VZV infection
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jul 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Costa Rica: 32
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Country: Number of subjects enrolled |
Panama: 34
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Country: Number of subjects enrolled |
Guatemala: 13
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Worldwide total number of subjects |
79
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
24
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Children (2-11 years) |
55
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at: Part A: 2 centers (1 in Panama, 1 in Costa Rica); Part B: 4 centers (2 in Panama, 1 in Costa Rica, 1 in Guatemala). | |||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 79 subjects (Part A: 26, Part B: 53) were enrolled in the study. | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Blinding implementation details |
The study was open label study, hence no blinding was performed
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Famciclovir: Single dose (Part A) | |||||||||||||||||||||
Arm description |
Subjects were orally administered with a single body weight stratified dose of famciclovir of 12.5 milligram (mg)/kilogram (kg) body weight with a dose escalation up to a maximum dose of 500 mg. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Famciclovir
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Investigational medicinal product code |
FAM810
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Other name |
Famvir
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered with a single-dose closest to 12.5 mg/kg body weight with a maximum dose of 500 mg.
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Arm title
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Famciclovir: Multiple doses (Part B) | |||||||||||||||||||||
Arm description |
Subjects were orally administered with famciclovir sprinkle capsules thrice daily (t.i.d.) with a dose separation of 8 hours for a period of 7 days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Famciclovir
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Investigational medicinal product code |
FAM810
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Other name |
Famvir
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were orally administered with a body weight stratified dose ranged from 150 mg to 500 mg t.i.d. of famciclovir sprinkle capsules with a dose separation of 8 hours for a period of 7 days.
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Baseline characteristics reporting groups
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Reporting group title |
Famciclovir: Single dose (Part A)
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Reporting group description |
Subjects were orally administered with a single body weight stratified dose of famciclovir of 12.5 milligram (mg)/kilogram (kg) body weight with a dose escalation up to a maximum dose of 500 mg. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Famciclovir: Multiple doses (Part B)
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Reporting group description |
Subjects were orally administered with famciclovir sprinkle capsules thrice daily (t.i.d.) with a dose separation of 8 hours for a period of 7 days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Subjects aged: 1 to <2 years (Part A)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 2 to <6 years (Part A)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 2 to <6 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 6 to <=12 years (Part A)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 6 to <12 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 1 to <2 years (Part B)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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Subject analysis set title |
Subjects aged: 2 to <6 years (Part B)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d.up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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Subject analysis set title |
Subjects aged: 6 to <=12 years (Part B)
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d.up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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End points reporting groups
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Reporting group title |
Famciclovir: Single dose (Part A)
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Reporting group description |
Subjects were orally administered with a single body weight stratified dose of famciclovir of 12.5 milligram (mg)/kilogram (kg) body weight with a dose escalation up to a maximum dose of 500 mg. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | ||
Reporting group title |
Famciclovir: Multiple doses (Part B)
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Reporting group description |
Subjects were orally administered with famciclovir sprinkle capsules thrice daily (t.i.d.) with a dose separation of 8 hours for a period of 7 days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | ||
Subject analysis set title |
Subjects aged: 1 to <2 years (Part A)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 2 to <6 years (Part A)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 2 to <6 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 6 to <=12 years (Part A)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 6 to <12 years were orally administered with a single body weight stratified dose of famciclovir of 12.5 mg/kg weight with a maximum dose of 500 mg.
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Subject analysis set title |
Subjects aged: 1 to <2 years (Part B)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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Subject analysis set title |
Subjects aged: 2 to <6 years (Part B)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d.up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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Subject analysis set title |
Subjects aged: 6 to <=12 years (Part B)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
All subjects aged between 1 to <2 years were orally administered with famciclovir sprinkle capsule thrice daily with a dose separation of 8 hours for a period of 7
days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d.up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg.
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End point title |
Time to maximum plasma concentration (Tmax) of famciclovir during Part A [1] | ||||||||||||||||
End point description |
Tmax was defined as the time to reach maximum plasma concentration. Penciclovir (metabolite of famciclovir) plasma concentrations were determined by using a validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. The limit of quantification was 0.15 microgram (µg)/millilitre (mL) for both compounds. The analysis was performed in pharmacokinetic analysis set (PAS) population, defined as all subjects who received at least one scheduled dose of famciclovir and provided all primary PK parameters in at least one treatment period.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Maximum plasma concentration (Cmax) of famciclovir during Part A [2] | ||||||||||||||||
End point description |
Cmax was defined as the maximum plasma concentration. Penciclovir (metabolite of famciclovir)plasma concentrations were determined by using a validated LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. The analysis was performed in PAS population.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the plasma concentration time curve from time zero to the time point of the last measurable concentration (AUC 0-tlast) of famciclovir during Part A [3] | ||||||||||||||||
End point description |
AUC 0-tlast was defined as the area under the plasma concentration time curve from time zero to the time point of the last measurable concentration. Penciclovir (metabolite of famciclovir)plasma concentrations were determined by using a validated LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. The analysis was performed in PAS population.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Area under the plasma concentration time curve from time zero to infinity (AUC 0-infinity) of famciclovir during Part A [4] | ||||||||||||||||
End point description |
AUC 0-infinity was defined as the area under the plasma concentration time curve from time zero to infinity. Penciclovir (metabolite of famciclovir) plasma concentrations were determined by using a validated LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. The analysis was performed in PAS population.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Terminal elimination half-life (T½) of famciclovir during Part A [5] | ||||||||||||||||
End point description |
T½ was defined as the terminal elimination half-life. Penciclovir (metabolite of famciclovir)plasma concentrations were determined by using a validated LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. The analysis was performed in PAS population.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Apparent oral clearance (CL/F) of famciclovir during Part A [6] | ||||||||||||||||
End point description |
CL/F was defined as the apparent oral clearance. Penciclovir (metabolite of famciclovir)plasma concentrations were determined by using a validated LC/MS/MS method. The limit of quantification was 0.15 µg/mL for both compounds. The analysis was performed in PAS population.
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End point type |
Primary
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End point timeframe |
At pre-dose, 1, 2, 3, 4, and 5 hours post treatment administration
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ONLY SUMMARY STATS ARE AVAILABLE |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with Adverse Events (AEs), Serious Adverse Events(SAEs), AE leading to discontinuation and who died [7] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population defined as all subjects who received at least one of the study treatment.
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End point type |
Primary
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End point timeframe |
From Day 1 up to Day 15
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: NO STATS COMPARING SAFETY |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with clinically significant laboratory abnormalities [8] | |||||||||||||||||||||||||||||||||||
End point description |
Subjects with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities. Laboratory values were assessed according to the National Cancer Institute-Common terminology criteria for Adverse Events (NCI-CTCAE). Hematology and clinical chemistry were
performed. The analysis was performed on the safety set.
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End point type |
Primary
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End point timeframe |
From Day 1 up to Day 15
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: NO STATS COMPARING SAFETY |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||
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End point title |
Assessment of acceptability of pediatric formulation during Part A | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessment of acceptability was done using a modified, 5-point facial hedonic scale, subjects or caregivers were asked to complete an assessment of study medication. Subjects marked the scale with their response of choice. The scale represented a balance of choices from ‘I did not like it’ to ‘I like it
very much’ with a mid-point of neither like nor dislike, with qualitative evaluation. The analysis was performed on the safety set.
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End point type |
Secondary
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End point timeframe |
At Day 1
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Assessment of acceptability of pediatric formulation during Part B | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessment of acceptability was done using a modified, 5-point facial hedonic scale, subjects orcaregivers were asked to complete an assessment of study medication. Subjects marked the scale with their response of choice. The scale represented a balance of choices from ‘I did not like it’ to ‘I like it
very much’ with a mid-point of neither like nor dislike, with qualitative evaluation. The analysis was performed on the safety set. Here, ‘clinic’ and ‘home’ signifies post-first dose in clinic and home respectively and day 8 have been reported for post-last dose at home.
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End point type |
Secondary
|
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End point timeframe |
From Day 1 to Day 8
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Adverse events information
|
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Timeframe for reporting adverse events |
Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
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Reporting groups
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Reporting group title |
Famciclovir: Multiple doses (Part B)
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Reporting group description |
Subjects were orally administered with famciclovir sprinkle capsules t.i.d. with a dose separation of 8 hours for a period of 7 days. Subjects were administered with a body weight stratified daily dose in 8-step from 150 mg t.i.d. up to a maximum of 500 mg t.i.d. Subjects who had weight >= 40 kg received a famciclovir dose of 500 mg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
07 Jul 2006 |
Dosing scheme for Part B was adjusted according to interim results from Part A of both studies (i.e. CFAM810B2303 and CFAM810B2304) and discussions with FDA. It also added a criterion to exclude subjects who weighed <9 kg and deleted the requirement that subjects without laboratory confirmation of their infection must discontinue drug. |
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17 Nov 2006 |
Requirement for PK and multiple-dose safety assessments in a cohort of subjects, 12 to 18 years of age and the upper age limit of the pediatric subjects to be studied from 12 to 18 years old was amended. The amendment created a new cohort for these adolescent subjects . |
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18 Jun 2007 |
Cancelled the requirement for inclusion of adolescent subjects in the study by deleting the new cohort (which had been designated as cohort 4 to include subjects 12 to 18 years of age), amending the upper age limit of the pediatric subjects to be studied from 18 back to 12 years, and deleting the requirement for
single-dose PK for 3 to 4 subjects in cohort 4. The amendment also readjusted the number of subjects per cohort in Part B to compensate for the removal of cohort 4. |
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Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
