Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00448227
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2007-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], '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'}]}, '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': 'There is typically a disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Famciclovir', 'description': 'Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.', 'otherNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics of Single Dose - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.17'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.17'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.58', 'upperLimit': '1.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \\<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.'}, {'type': 'SECONDARY', 'title': 'Safety Assessed by AEs, SAEs', 'timeFrame': '38 days', 'description': "AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Assessed by Labs', 'timeFrame': '2 days', 'description': 'Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Significant emesis occurred', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Spit out most of the dose, ingested less than half', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Spit out some of the dose, ingested at least 50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Able to ingest and retain dose', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after dosing', 'description': 'Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:\n\n1. Significant emesis occurred,\n2. Infant spit out most of the dose ingesting less than half of what was administered,\n3. Infant spit out some of the dose, but ingested at least 50% of what was administered,\n4. Infant was able to ingest and retain the dose administered', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}, {'type': 'SECONDARY', 'title': "Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Very badly / unacceptable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Badly but accepted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neither good nor bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Well accepted', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Very well accepted', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after dosing', 'description': 'Assessed by the caregiver using a 5-point scale immediately after dosing:\n\n1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation\n2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose\n3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose\n4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose\n5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Single Dose - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '3.24', 'spread': '1.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by Cmax - The maximum plasma concentration of study medication', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \\<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Single Dose - AUC(0-tlast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '8.68', 'spread': '2.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.', 'unitOfMeasure': '(μg/mL)•h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \\<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Single Dose - AUC(0-6h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '8.77', 'spread': '2.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).', 'unitOfMeasure': '(μg/mL)•h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to \\<3 months age group who did not have PK samples taken due to emesis reported after study medication administration.'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir: Infants 1 to <3 Months', 'description': 'Infants 1 to \\<3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG001', 'title': 'Famciclovir: Infants 3 to <6 Months', 'description': 'Infants 3 to \\<6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG002', 'title': 'Famciclovir: Infants 6 to 12 Months', 'description': 'Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}, {'id': 'OG003', 'title': 'Total'}], 'classes': [{'title': 'Very badly / unacceptable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Badly but accepted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neither good nor bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Well accepted', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Very well accepted', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after dosing', 'description': 'Assessed by the study personnel using a 5-point scale after dosing:\n\n1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation\n2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose\n3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose\n4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose\n5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Famciclovir', 'description': 'Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Famciclovir', 'description': 'Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '3.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '1 to <3 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '3 to <6 months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '6 to 12 months', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-09', 'studyFirstSubmitDate': '2007-03-15', 'resultsFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-12', 'studyFirstPostDateStruct': {'date': '2007-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of Single Dose - Tmax', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.'}, {'measure': 'Pharmacokinetics of Single Dose - Cmax', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by Cmax - The maximum plasma concentration of study medication'}, {'measure': 'Pharmacokinetics of Single Dose - AUC(0-tlast)', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.'}, {'measure': 'Pharmacokinetics of Single Dose - AUC(0-6h)', 'timeFrame': 'Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.', 'description': 'Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).'}], 'secondaryOutcomes': [{'measure': 'Safety Assessed by AEs, SAEs', 'timeFrame': '38 days', 'description': "AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose."}, {'measure': 'Safety Assessed by Labs', 'timeFrame': '2 days', 'description': 'Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.'}, {'measure': 'Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.', 'timeFrame': '30 minutes after dosing', 'description': 'Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:\n\n1. Significant emesis occurred,\n2. Infant spit out most of the dose ingesting less than half of what was administered,\n3. Infant spit out some of the dose, but ingested at least 50% of what was administered,\n4. Infant was able to ingest and retain the dose administered'}, {'measure': "Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver", 'timeFrame': 'Immediately after dosing', 'description': 'Assessed by the caregiver using a 5-point scale immediately after dosing:\n\n1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation\n2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose\n3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose\n4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose\n5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing'}, {'measure': 'Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel', 'timeFrame': 'Immediately after dosing', 'description': 'Assessed by the study personnel using a 5-point scale after dosing:\n\n1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation\n2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose\n3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose\n4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose\n5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infants, Herpes simplex infection'], 'conditions': ['Herpes Simplex']}, 'referencesModule': {'references': [{'pmid': '20160046', 'type': 'DERIVED', 'citation': 'Blumer J, Rodriguez A, Sanchez PJ, Sallas W, Kaiser G, Hamed K. Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother. 2010 May;54(5):2032-41. doi: 10.1128/AAC.01508-09. Epub 2010 Feb 16.'}], 'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients from 1 month up to 1 year of age with herpes simplex infection\n\nExclusion Criteria:\n\n* Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00448227', 'briefTitle': 'Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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 Less Than 1 Year of Age With Herpes Simplex Virus Infections', 'orgStudyIdInfo': {'id': 'CFAM810B2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Famciclovir', 'description': 'Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.', 'interventionNames': ['Drug: famciclovir']}], 'interventions': [{'name': 'famciclovir', 'type': 'DRUG', 'otherNames': ['Famvir'], 'description': 'Administered orally as a single individualized dose between 25-200 mg based on body weight.', 'armGroupLabels': ['Famciclovir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pediatric Infectious Disease Of University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Archana Chatterjee', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "University Hospital Cased Medical Center Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis'}, {'name': 'Dr. Jeffery L. Blumer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Hospital Cased Medical Center Rainbow Babies and Children's Hospital, Cleveland, OH"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}