Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
Study NCT ID:
NCT05602766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ngenla Subcutaneous Injection Special Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004393', 'term': 'Dwarfism, Pituitary'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D007018', 'term': 'Hypopituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723339', 'term': 'somatrogon'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-04-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients reporting Adverse Events (AEs)', 'timeFrame': 'up to 5 years'}, {'measure': 'Incidence of Glucose metabolism disorders per exposure period', 'timeFrame': 'up to 5 years'}, {'measure': 'Incidence of Neoplasm per exposure period', 'timeFrame': 'up to 5 years'}, {'measure': 'Annual growth rate (cm/year)', 'timeFrame': 'up to 5 years'}, {'measure': 'Growth rate standard deviation score (SDS) for chronological age', 'timeFrame': 'up to 5 years'}, {'measure': 'Change in height SDS for chronological age and time-course of height SDS for chronological age', 'timeFrame': 'up to 5 years'}, {'measure': 'Proportion of reported Adverse Events', 'timeFrame': 'up to 5 years'}]}, 'conditionsModule': {'keywords': ['Growth hormone deficiency (GHD)', 'Recombinant human growth hormone (hGH)', 'once-weekly injection', 'Somatrogon'], 'conditions': ['Growth Hormone Deficiency Without Epiphyseal Closure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C0311011', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.\n\nRegistration criteria of this study are the patients who:\n\n* Have GHD without epiphyseal closure and receiving Ngenla for the first time.\n* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.\n\nAll patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.\n\nPatients will be followed up from the date of first Ngenla treatment until November 30, 2027.', 'detailedDescription': 'This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with GHD without epiphyseal closure who received NGENLA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients who satisfy all of the registration criteria are subject to this study.\n\nRegistration criteria\n\n1. Patients with GHD without epiphyseal closure who receive this drug for the first time after the date of contract for this study.\n2. Boys who are less than 15 years and girls who are less than 13 years of chronological age at the start of treatment with this drug.'}, 'identificationModule': {'nctId': 'NCT05602766', 'briefTitle': 'Ngenla Subcutaneous Injection Special Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Ngenla® Subcutaneous Injection Special Investigation', 'orgStudyIdInfo': {'id': 'C0311011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NGENLA (Somatrogon)', 'description': 'Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon)', 'interventionNames': ['Drug: NGENLA (Somatrogon)']}], 'interventions': [{'name': 'NGENLA (Somatrogon)', 'type': 'DRUG', 'description': 'Dosage, Frequency: Refer to the latest package insert.', 'armGroupLabels': ['NGENLA (Somatrogon)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}