Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-01 @ 10:42 PM
Study NCT ID:
NCT01959295
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2013-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of ASP2151 in Herpes Simplex Patients
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': 'C568714', 'term': 'ASP2151'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinfo@mii.maruho.co.jp', 'phone': '+81-75-325-3255', 'title': 'Maruho Co.,Ltd. Kyoto R&D Center', 'organization': 'Clinical Development Dept.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '29 days', 'description': 'The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug.\n\nThe two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'ASP2151', 'description': '200 mg once daily', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 309, 'otherNumAffected': 69, 'seriousNumAtRisk': 309, 'deathsNumAffected': 128, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 29, 'seriousNumAtRisk': 157, 'deathsNumAffected': 59, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Beta-N-acetyl-D-glucosaminidase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Fibrin degradation products increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}, {'term': 'Alpha 1 microglobulin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 309, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Ver. 16.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Healing by Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP2151', 'description': 'ASP2151: 200 mg once daily'}, {'id': 'OG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo: once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'groupId': 'OG000'}, {'value': '69.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5086', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '8days', 'description': 'The percentage of participants achieving lesion healing by Day 8 of study treatment', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS). The FAS was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.'}, {'type': 'SECONDARY', 'title': 'Time to Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP2151', 'description': '200 mg once daily'}, {'id': 'OG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '9'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '29days', 'description': 'The criteria for determining healing are as follows:\n\n1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved.\n2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.\n3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions', 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS). The FAS was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.'}, {'type': 'SECONDARY', 'title': 'Time to Complete Crusting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP2151', 'description': '200 mg once daily'}, {'id': 'OG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '29days', 'description': 'The criteria for complete crust formation are outlined as follows:\n\n1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required).\n2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.\n3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.', 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS). The FAS was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.'}, {'type': 'SECONDARY', 'title': 'Time to Virus Disappearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP2151', 'description': '200 mg once daily'}, {'id': 'OG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '29days', 'description': "The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site.", 'unitOfMeasure': 'day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS). The FAS was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASP2151', 'description': '200 mg once daily'}, {'id': 'FG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Clinical laboratory value is ineligible on day 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ASP2151', 'description': '200mg once daily'}, {'id': 'BG001', 'title': 'ASP2151 Placebo', 'description': 'ASP2151 placebo once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '40.4', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease type', 'classes': [{'categories': [{'title': 'Labial/facial herpes', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}, {'title': 'Recurrent genital herpes', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS). The FAS was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2013-09-26', 'resultsFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2013-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-02', 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Healing by Day 8', 'timeFrame': '8days', 'description': 'The percentage of participants achieving lesion healing by Day 8 of study treatment'}], 'secondaryOutcomes': [{'measure': 'Time to Healing', 'timeFrame': '29days', 'description': 'The criteria for determining healing are as follows:\n\n1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved.\n2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.\n3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions'}, {'measure': 'Time to Complete Crusting', 'timeFrame': '29days', 'description': 'The criteria for complete crust formation are outlined as follows:\n\n1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required).\n2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.\n3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.'}, {'measure': 'Time to Virus Disappearance', 'timeFrame': '29days', 'description': "The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site."}]}, 'conditionsModule': {'conditions': ['Herpes Simplex']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.', 'detailedDescription': 'A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated\n\n * Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules\n * Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region\n2. Patients who can start receiving the study drug within 48 hours after onset of rash\n3. Age: 20 years or older, but younger than 80 years\n\nExclusion Criteria:\n\n1. Patients who are not expected to have an adequate response to oral antiviral medication\n2. An extreme decline in immune function\n3. Presence of serious complications\n4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:\n\n * AST or ALT ≥ 2.5 x upper limit of normal\n * Platelet count \\< lower limit of normal\n * Serum creatinine ≥ 1.5 mg/dL\n * Creatinine clearance \\< 30 mL/min\n5. Current or previous history of malignant tumor within 5 years before informed consent\n6. Diagnosis of autoimmune disease\n7. Evidence of bone marrow suppression'}, 'identificationModule': {'nctId': 'NCT01959295', 'briefTitle': 'Phase III Study of ASP2151 in Herpes Simplex Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Co., Ltd.'}, 'officialTitle': 'Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -', 'orgStudyIdInfo': {'id': 'M522101-J11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP2151', 'interventionNames': ['Drug: ASP2151']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ASP2151 placebo', 'interventionNames': ['Drug: ASP2151 placebo']}], 'interventions': [{'name': 'ASP2151', 'type': 'DRUG', 'description': '200 mg once daily', 'armGroupLabels': ['ASP2151']}, {'name': 'ASP2151 placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['ASP2151 placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Nakano-ku', 'state': 'Tokyo', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}