Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT07229820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721066', 'term': 'ZSP1273'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Alleviation of Symptoms', 'timeFrame': 'DAY1~DAY15', 'description': 'Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'DAY1~DAY15'}, {'measure': 'Plasma concentrations of ZSP1273', 'timeFrame': 'DAY1~DAY15'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza A']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in China. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ZSP1273 in the treatment of Acute Uncomplicated influenza A in adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants and their guardians who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately.\n2. Male or female participants aged ≥ 2 to ≤11 years at the time of signing the informed consent form.\n3. Participants with a diagnosis of influenza virus infection confirmed by all of the following:\n\n 1. Positive rapid antigen test (RAT) for influenza with nasal or throat swabs;\n 2. The time interval between the onset of symptoms and enrollment is 48 hours or less;\n 3. Fever ≥ 38ºC (axillary temperature); and at least one following respiratory symptoms associated with influenza virus infection is present\n\nExclusion Criteria:\n\n1. Participants with severe influenza virus infection；\n2. Participants with any medical history in gastrointestinal that interferes with the absorption of drugs；\n3. Immunodeficiency,including malignant tumor,organ or marrow transplant,human immunodeficiency virus \\[HIV\\] infection,or patients receiving immunosuppressant therapy 3 months prior to enrollment；\n4. Have received any other investigational products within 3 months prior to dosing；\n5. Positive urine pregnancy test；\n6. Participants with concurrent infections requiring antimicrobial therapy；\n7. Participants who are considered inappropriate for the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT07229820', 'briefTitle': 'Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Raynovent Biotech Co., Ltd'}, 'officialTitle': 'A Randomized, Double-blind Phase III Clinical Study of ZSP1273 Tablets Compared With Placebo in Children 12-17 Years Old With Acute Uncomplicated Influenza A', 'orgStudyIdInfo': {'id': 'ZSP1273-25-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZSP1273', 'interventionNames': ['Drug: ZSP1273']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ZSP1273', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['ZSP1273']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Raynovent Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}