Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT06288334
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-24', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-02-24', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration', 'timeFrame': '0.5 ~ 48 hours before and after administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Disease', 'Children']}, 'descriptionModule': {'briefSummary': 'To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).\n2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.\n3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.\n4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.\n\nExclusion Criteria:\n\n1. Abnormal liver function (ALT or AST \\> 2 times the upper limit of normal).\n2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \\< 10 mL/min)\n3. Electrolyte abnormalities (potassium or magnesium \\< 0.8 times lower limit of normal, \\> 1.2 times upper limit of normal)\n4. Children who were allergic to cetirizine or had a history of serious adverse reactions.\n5. Pediatric patients with unstable vital signs.'}, 'identificationModule': {'nctId': 'NCT06288334', 'briefTitle': 'Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children', 'orgStudyIdInfo': {'id': 'PUTH PD_V 1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric patients treated with cetirizine', 'description': 'Pediatric patients who were being treated with cetirizine to fight allergic diseases.', 'interventionNames': ['Other: 1-3 Cetirizine Pharmacokinetic samples']}], 'interventions': [{'name': '1-3 Cetirizine Pharmacokinetic samples', 'type': 'OTHER', 'description': 'Limited sampling strategy was used in this study. For each child, only 1\\~3 blood samples were collected before and after cetirizine administration.', 'armGroupLabels': ['Pediatric patients treated with cetirizine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yafen Li', 'role': 'CONTACT', 'email': 'liyafen314159@163.com', 'phone': '18222566785'}, {'name': 'Wei Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dongyang Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Dongyang Liu', 'role': 'CONTACT', 'email': 'liudongyang@vip.sina.com', 'phone': '(86)010-82266658'}, {'name': 'Yafen Li', 'role': 'CONTACT', 'email': 'liyafen314159@163.com', 'phone': '18222566785'}], 'overallOfficials': [{'name': 'Wei Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dongyang Liu', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}