Trial Outcomes & Findings for Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection (NCT NCT00098059)
NCT ID: NCT00098059
Last Updated: 2013-04-25
Results Overview
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
8 hours and 24 hours after study drug administration (Part A)
Results posted on
2013-04-25
Participant Flow
Participant milestones
| Measure |
Part A (Single-dose of Famciclovir)
Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
|
Part B (Multiple-dose of Famciclovir)
Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
47
|
|
Overall Study
COMPLETED
|
27
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Baseline characteristics by cohort
| Measure |
Part A (Single-dose of Famciclovir)
n=27 Participants
Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
|
Part B (Multiple-dose of Famciclovir)
n=47 Participants
Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
1 to <2 years
|
4 participants
n=99 Participants
|
13 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Age, Customized
2 to <6 years
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Age, Customized
6 to <=12 years
|
8 participants
n=99 Participants
|
18 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Age, Customized
13 to <=18 years
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 hours and 24 hours after study drug administration (Part A)Population: Includes all 27 patients enrolled in Part A of the study.
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=13 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Patients with AEs
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Gastrointestinal disorders
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Nervous system disorders
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
General disorders and administration site
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Infections and infestations
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
Skin and subcutaneous tissue disorders
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dosePopulation: Includes all 27 patients enrolled in Part A of the study.
PK parameter; penciclovir is the active metabolite of famciclovir.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=13 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
|
2.84 μg/mL
Full Range 1.25 • Interval 1.42 to 4.47
|
2.44 μg/mL
Full Range 0.94 • Interval 0.42 to 3.81
|
2.82 μg/mL
Full Range 0.65 • Interval 1.52 to 3.79
|
1.89 μg/mL
Interval 1.06 to 2.72
|
PRIMARY outcome
Timeframe: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dosePopulation: Includes all 27 patients enrolled in Part A of the study.
PK parameter; penciclovir is the active metabolite of famciclovir.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=13 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
|
1.21 hours
Interval 1.0 to 1.5
|
1.07 hours
Interval 1.0 to 4.03
|
1.00 hours
Interval 1.0 to 2.07
|
1.47 hours
Interval 0.97 to 1.97
|
PRIMARY outcome
Timeframe: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dosePopulation: Includes 26 of 27 patients enrolled in Part A of the study.
PK parameter; penciclovir is the active metabolite of famciclovir.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=12 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
|
6.17 (μg/mL)h
Full Range 2.42 • Interval 3.43 to 8.99
|
6.85 (μg/mL)h
Full Range 1.55 • Interval 3.19 to 9.12
|
8.15 (μg/mL)h
Full Range 1.01 • Interval 6.49 to 9.71
|
5.93 (μg/mL)h
Full Range 0 • Interval 4.84 to 7.01
|
PRIMARY outcome
Timeframe: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dosePopulation: Includes 26 of 27 patients enrolled in Part A of the study.
PK parameter; penciclovir is the active metabolite of famciclovir.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=12 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Apparent Oral Clearance of Penciclovir (CL/F)
|
20.8 L/h
Full Range 8.5 • Interval 11.0 to 28.8
|
25.1 L/h
Full Range 4.3 • Interval 18.1 to 33.3
|
43.7 L/h
Full Range 9.6 • Interval 32.4 to 60.8
|
68.8 L/h
Full Range 0 • Interval 56.2 to 81.5
|
PRIMARY outcome
Timeframe: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dosePopulation: Includes 26 of 27 patients enrolled in Part A of the study.
PK parameter; penciclovir is the active metabolite of famciclovir
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=12 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
|
1.09 hours
Full Range 0.08 • Interval 1.01 to 1.18
|
1.36 hours
Full Range 0.20 • Interval 1.1 to 1.7
|
1.60 hours
Full Range 0.25 • Interval 1.3 to 2.11
|
1.86 hours
Interval 1.6 to 2.12
|
PRIMARY outcome
Timeframe: Administered 2 times daily over 7 daysPopulation: Includes 47 patients enrolled in Part B of the study.
A patient with multiple AEs within the primary system organ class is counted only once in total row.
Outcome measures
| Measure |
1 to < 2 Years
n=13 Participants
|
2 to <6 Years
n=16 Participants
|
6 to <13 Years
n=18 Participants
|
13 to <=18 Years
|
|---|---|---|---|---|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Patients with AEs
|
6 participants
|
8 participants
|
12 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Vascular disorders
|
0 participants
|
0 participants
|
2 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Gastrointestinal disorders
|
4 participants
|
3 participants
|
6 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Nervous system disorders
|
0 participants
|
2 participants
|
5 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
General disorders and administration site
|
3 participants
|
1 participants
|
1 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Respiratory, thoracic and mediastinal disorders
|
1 participants
|
1 participants
|
2 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Infections and infestations
|
3 participants
|
0 participants
|
0 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Skin and subcutaneous tissue disorders
|
1 participants
|
2 participants
|
0 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Injury, poisoning and procedural complications
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Investigations
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
Metabolism and nutrition disorders
|
1 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, after swallowing the dose.Population: Includes all 27 patients enrolled in Part A of the study.
Overall acceptability of the study medication was determined by caretaker response.
Outcome measures
| Measure |
1 to < 2 Years
n=4 Participants
|
2 to <6 Years
n=13 Participants
|
6 to <13 Years
n=8 Participants
|
13 to <=18 Years
n=2 Participants
|
|---|---|---|---|---|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Badly
|
1 participants
|
4 participants
|
0 participants
|
2 participants
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Neither bad nor good
|
1 participants
|
1 participants
|
4 participants
|
0 participants
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Well
|
2 participants
|
8 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 at clinic: after swallowing first dosePopulation: Includes all 47 patients enrolled in Part B of the study.
Overall acceptability of the study medication was determined by caretaker response.
Outcome measures
| Measure |
1 to < 2 Years
n=13 Participants
|
2 to <6 Years
n=16 Participants
|
6 to <13 Years
n=18 Participants
|
13 to <=18 Years
|
|---|---|---|---|---|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Badly
|
9 participants
|
6 participants
|
7 participants
|
—
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Neither bad nor good
|
2 participants
|
1 participants
|
2 participants
|
—
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Well
|
2 participants
|
9 participants
|
9 participants
|
—
|
SECONDARY outcome
Timeframe: Day 8 at home: after swallowing last dosePopulation: Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to \<6 years and 6 to \<=12 years groups.
Overall acceptability of study medication was determined by caretaker response.
Outcome measures
| Measure |
1 to < 2 Years
n=13 Participants
|
2 to <6 Years
n=16 Participants
|
6 to <13 Years
n=18 Participants
|
13 to <=18 Years
|
|---|---|---|---|---|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Well
|
3 participants
|
7 participants
|
11 participants
|
—
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Badly
|
7 participants
|
5 participants
|
3 participants
|
—
|
|
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Neither bad nor good
|
3 participants
|
3 participants
|
3 participants
|
—
|
Adverse Events
Part A (Single-dose of Famciclovir)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B (Multiple-dose of Famciclovir)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A (Single-dose of Famciclovir)
n=27 participants at risk
Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
|
Part B (Multiple-dose of Famciclovir)
n=47 participants at risk
Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
4.3%
2/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
0.00%
0/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
8.5%
4/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
4.3%
2/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Infections and infestations
Furuncle
|
3.7%
1/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
0.00%
0/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
0.00%
0/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
10.6%
5/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
8.5%
4/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
6.4%
3/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
6.4%
3/47 • Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER