Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-26 @ 12:26 PM
Study NCT ID:
NCT00098059
Status:
COMPLETED
Last Update Posted:
2013-04-25
First Post:
2004-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Guatemala']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006560', 'term': 'Herpes Labialis'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077595', 'term': 'Famciclovir'}], 'ancestors': [{'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A (Single-dose of Famciclovir)', 'description': '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.', 'otherNumAtRisk': 27, 'otherNumAffected': 5, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part B (Multiple-dose of Famciclovir)', 'description': '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.', 'otherNumAtRisk': 47, 'otherNumAffected': 23, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <13 Years'}, {'id': 'OG003', 'title': '13 to <=18 Years'}], 'classes': [{'title': 'Badly', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neither bad nor good', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Well', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, after swallowing the dose.', 'description': 'Overall acceptability of the study medication was determined by caretaker response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all 27 patients enrolled in Part A of the study.'}, {'type': 'SECONDARY', 'title': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <13 Years'}, {'id': 'OG003', 'title': '13 to <=18 Years'}], 'classes': [{'title': 'Badly', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Neither bad nor good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Well', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 at clinic: after swallowing first dose', 'description': 'Overall acceptability of the study medication was determined by caretaker response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all 47 patients enrolled in Part B of the study.'}, {'type': 'SECONDARY', 'title': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <13 Years'}, {'id': 'OG003', 'title': '13 to <=18 Years'}], 'classes': [{'title': 'Badly', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Neither bad nor good', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Well', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 at home: after swallowing last dose', 'description': 'Overall acceptability of study medication was determined by caretaker response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to <= 18 Years'}], 'classes': [{'title': 'Patients with AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'General disorders and administration site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours and 24 hours after study drug administration (Part A)', 'description': 'A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration of Penciclovir (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to <= 18 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '2.84', 'spread': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '4.47'}, {'value': '2.44', 'spread': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '3.81'}, {'value': '2.82', 'spread': '0.65', 'groupId': 'OG002', 'lowerLimit': '1.52', 'upperLimit': '3.79'}, {'value': '1.89', 'groupId': 'OG003', 'lowerLimit': '1.06', 'upperLimit': '2.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to < =18 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.03'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.07'}, {'value': '1.47', 'groupId': 'OG003', 'lowerLimit': '0.97', 'upperLimit': '1.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to <= 18 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '6.17', 'spread': '2.42', 'groupId': 'OG000', 'lowerLimit': '3.43', 'upperLimit': '8.99'}, {'value': '6.85', 'spread': '1.55', 'groupId': 'OG001', 'lowerLimit': '3.19', 'upperLimit': '9.12'}, {'value': '8.15', 'spread': '1.01', 'groupId': 'OG002', 'lowerLimit': '6.49', 'upperLimit': '9.71'}, {'value': '5.93', 'spread': '0', 'groupId': 'OG003', 'lowerLimit': '4.84', 'upperLimit': '7.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.', 'unitOfMeasure': '(μg/mL)h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes 26 of 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance of Penciclovir (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to <= 18 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '8.5', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '28.8'}, {'value': '25.1', 'spread': '4.3', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '33.3'}, {'value': '43.7', 'spread': '9.6', 'groupId': 'OG002', 'lowerLimit': '32.4', 'upperLimit': '60.8'}, {'value': '68.8', 'spread': '0', 'groupId': 'OG003', 'lowerLimit': '56.2', 'upperLimit': '81.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes 26 of 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Half-life of Penciclovir (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <=12 Years'}, {'id': 'OG003', 'title': '13 to <= 18 Years'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.08', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '1.18'}, {'value': '1.36', 'spread': '0.20', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '1.70'}, {'value': '1.60', 'spread': '0.25', 'groupId': 'OG002', 'lowerLimit': '1.30', 'upperLimit': '2.11'}, {'value': '1.86', 'groupId': 'OG003', 'lowerLimit': '1.60', 'upperLimit': '2.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes 26 of 27 patients enrolled in Part A of the study.'}, {'type': 'PRIMARY', 'title': 'Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 to < 2 Years'}, {'id': 'OG001', 'title': '2 to <6 Years'}, {'id': 'OG002', 'title': '6 to <13 Years'}, {'id': 'OG003', 'title': '13 to <=18 Years'}], 'classes': [{'title': 'Patients with AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vascular disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolism and nutrition disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Administered 2 times daily over 7 days', 'description': 'A patient with multiple AEs within the primary system organ class is counted only once in total row.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes 47 patients enrolled in Part B of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A (Single-dose of Famciclovir)', 'description': '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.'}, {'id': 'FG001', 'title': 'Part B (Multiple-dose of Famciclovir)', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A (Single-dose of Famciclovir)', 'description': 'Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).'}, {'id': 'BG001', 'title': 'Part B (Multiple-dose of Famciclovir)', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '1 to <2 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '2 to <6 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '6 to <=12 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': '13 to <=18 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2004-12-02', 'resultsFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2004-12-02', 'lastUpdatePostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-20', 'studyFirstPostDateStruct': {'date': '2004-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.', 'timeFrame': '8 hours and 24 hours after study drug administration (Part A)', 'description': 'A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.'}, {'measure': 'Maximum Observed Plasma Concentration of Penciclovir (Cmax)', 'timeFrame': 'plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.'}, {'measure': 'Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.'}, {'measure': 'Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.'}, {'measure': 'Apparent Oral Clearance of Penciclovir (CL/F)', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir.'}, {'measure': 'Apparent Terminal Elimination Half-life of Penciclovir (T1/2)', 'timeFrame': 'Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose', 'description': 'PK parameter; penciclovir is the active metabolite of famciclovir'}, {'measure': 'Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.', 'timeFrame': 'Administered 2 times daily over 7 days', 'description': 'A patient with multiple AEs within the primary system organ class is counted only once in total row.'}], 'secondaryOutcomes': [{'measure': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.', 'timeFrame': 'Day 1, after swallowing the dose.', 'description': 'Overall acceptability of the study medication was determined by caretaker response.'}, {'measure': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.', 'timeFrame': 'Day 1 at clinic: after swallowing first dose', 'description': 'Overall acceptability of the study medication was determined by caretaker response.'}, {'measure': 'Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study', 'timeFrame': 'Day 8 at home: after swallowing last dose', 'description': 'Overall acceptability of study medication was determined by caretaker response.'}]}, 'conditionsModule': {'keywords': ['herpes simplex', 'cold sores', 'fever blisters', 'children', 'Famvir', 'famciclovir'], 'conditions': ['Herpes Simplex']}, 'referencesModule': {'references': [{'pmid': '19273678', 'type': 'DERIVED', 'citation': 'Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History or laboratory evidence of herpes simplex infection\n* Clinical evidence or suspicion of herpes simplex infection\n\nExclusion Criteria:\n\n* Patients unable to swallow\n* Concomitant use of probenecid\n* Positive pregnancy test\n\nAdditional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228'}, 'identificationModule': {'nctId': 'NCT00098059', 'briefTitle': 'Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CFAM810B2303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Famciclovir, pediatric oral formulation', 'description': 'single-arm', 'interventionNames': ['Drug: Famciclovir']}], 'interventions': [{'name': 'Famciclovir', 'type': 'DRUG', 'description': 'Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle', 'armGroupLabels': ['Famciclovir, pediatric oral formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1711', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202-3830', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kosair Charities Pediatric Clinical Research Unit', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-3362', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York at', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine/Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'David', 'state': 'Chiriquí Province', 'country': 'Panama', 'facility': 'Panama Minister of Health', 'geoPoint': {'lat': 8.42729, 'lon': -82.43085}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Panama Minister of Health', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}