Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT07099157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020235', 'term': 'brivudine'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Blinded Investigator conduct the follow-ups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day 30 numeric pain rating scale (NPRS)', 'timeFrame': 'Day 30', 'description': 'Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.'}], 'secondaryOutcomes': [{'measure': 'numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90', 'timeFrame': 'Day 3, Day 7, Day 14, Day 90', 'description': 'Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.'}, {'measure': 'Incidence of PHN', 'timeFrame': 'Day 90', 'description': 'Incidence of Postherpetic Neuralgia'}, {'measure': 'skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90', 'timeFrame': 'Day 3, Day 7, Day 14, Day 30, Day 90', 'description': 'whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers'}, {'measure': 'Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90', 'timeFrame': 'Day 3, Day 7, Day 14, Day 30 and Day 90', 'description': 'Percentage of body surface area (BSA%) affected by lesions on Day 3, Day 7, Day 14, Day 30 and Day 90'}, {'measure': 'cessation of new lesion formation', 'timeFrame': 'Day 3, Day 7, Day 14, Day 30 and Day 90', 'description': 'whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90'}, {'measure': 'complete crusting of all lesions', 'timeFrame': 'Day 3, Day 7, Day 14, Day 30 and Day 90', 'description': 'whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90'}, {'measure': 'Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From baseline to Day 30', 'description': 'Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herpes Zoster', 'Brivudine', 'pain', 'treatment'], 'conditions': ['Herpes Zoster']}, 'descriptionModule': {'briefSummary': 'This multicenter RCT aims to compare the efficacy and safety of Brivudine versus Famciclovir in treating acute herpes zoster. Primary objective: Evaluate pain reduction via Numeric Pain Rating Scale (NPRS) at Day 30. Secondary objectives: Compare NPRS at Day 3/Day 7/Day 14/Day 90, time to lesion resolution, Postherpetic Neuralgia (PHN) incidence, and safety.', 'detailedDescription': 'A randomized controlled trial enrolling 140 participants from 5 centers in China. Patients receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days. Follow-ups occur at Day 3, Day 7, Day 14, Day 30, Day 90. Primary endpoint: Numeric Pain Rating Scale (NPRS) at Day 30; secondary endpoints: NPRS at other timepoints, lesion healing time, Postherpetic Neuralgia (PHN) rate, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Signed Informed Consent Form;\n3. Female subjects must not plan for pregnancy or oocyte donation from screening until 1 week after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:\n\n * Barrier methods: Condom or barrier cap (diaphragm or cervical cap);\n * Intrauterine device (IUD) or intrauterine system (IUS);\n * Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;\n * Other investigator-confirmed highly effective physical contraception.\n\nExclusion Criteria:\n\n1. Allergy to brivudine, famciclovir, or penciclovir;\n2. Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine);\n3. Cancer patients currently undergoing chemotherapy;\n4. Pregnant or lactating women;\n5. Parkinson's disease;\n6. Any condition deemed inappropriate for study participation by the investigator."}, 'identificationModule': {'nctId': 'NCT07099157', 'briefTitle': 'Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'M20250600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brivudine Group', 'interventionNames': ['Drug: Brivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Famciclovir Group', 'interventionNames': ['Drug: Famciclovir']}], 'interventions': [{'name': 'Brivudine', 'type': 'DRUG', 'description': 'brivudine 125 mg per dose, once daily, 7 days', 'armGroupLabels': ['Brivudine Group']}, {'name': 'Famciclovir', 'type': 'DRUG', 'description': 'orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days', 'armGroupLabels': ['Famciclovir Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Hong Cai, M.D.', 'role': 'CONTACT', 'email': 'ch1031@163.com', 'phone': '008615116908928'}], 'facility': 'Air Force Medical Center, PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Dongmei Zhou, M.D.', 'role': 'CONTACT', 'email': '52176857@163.com', 'phone': '008613811201580'}], 'facility': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Xiaowen Wang, M.D.', 'role': 'CONTACT', 'email': 'xiaowenpku@126.com', 'phone': '008615901254602'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Haiping Zhang, M.D.', 'role': 'CONTACT', 'email': 'zhanghaiping@xwhosp.org', 'phone': '008613701205765'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jin-Zhu Guo, M.D.', 'role': 'CONTACT', 'email': 'guojinzhu_826@163.com', 'phone': '008613521115717'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, {'name': 'Beijing Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Dermatology', 'investigatorFullName': 'Guo Jin-Zhu', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}