Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05171751
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-19', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-12-19', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood glucose', 'timeFrame': '1 year', 'description': 'Maintain target blood glucose ≥3.3mmo/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Hyperinsulinaemic Hypoglycaemia', 'Octreotide Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.', 'detailedDescription': 'Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with congenital hyperinsulinemia who received octreotide subcutaneous injection after diazazine treatment failed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.\n2. patients treated with octreotide subcutaneous injection.\n\nExclusion Criteria:\n\n1. Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide\n2. Secondary hypoglycemia caused by diseases other than CHI\n3. Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.\n4. Patients who intervene/interfere with octreotide treatment regimen for parental reasons'}, 'identificationModule': {'nctId': 'NCT05171751', 'acronym': 'BCH', 'briefTitle': 'Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': "Beijing Children's Hospital, Capital Medical University, National Center for Children's Health", 'orgStudyIdInfo': {'id': 'octreotide-CHI-2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Octreotide Injection', 'type': 'DRUG', 'otherNames': ['glucose'], 'description': 'Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Endocrinology, Genetics, Metabolism', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'bingyan cao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "doctor of Beijing children's hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Chunxiu Gong', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}