Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT00747604
Status:
TERMINATED
Last Update Posted:
2020-11-06
First Post:
2008-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004392', 'term': 'Dwarfism'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604197', 'term': 'mecasermin'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1378}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Shortage of Increlex supply', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2008-09-03', 'studyFirstSubmitQcDate': '2008-09-04', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure', 'timeFrame': 'periodically assessed over the course of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Growth Hormone (GH) Insensitivity Syndrome', 'Insulin-like Growth Factor Deficiency (IGFD)', 'Short Stature', 'Insulin-like Growth Factor (IGF-1)', 'Growth'], 'conditions': ['Primary Insulin-like Growth Factor-1 Deficiency']}, 'descriptionModule': {'briefSummary': 'This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin \\[rDNA origin\\] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.', 'detailedDescription': "The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.\n\nThe collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.\n* Patients receiving Increlex® by a qualified practitioner may be enrolled\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00747604', 'briefTitle': 'IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex', 'orgStudyIdInfo': {'id': 'W-TG-52800-010 (MS305)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Increlex patients', 'description': 'Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.', 'interventionNames': ['Biological: mecasermin [rDNA origin] injection']}], 'interventions': [{'name': 'mecasermin [rDNA origin] injection', 'type': 'BIOLOGICAL', 'otherNames': ['Increlex®'], 'description': 'As prescribed by the physician.', 'armGroupLabels': ['Increlex patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Ipsen Central Contact', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'overallOfficials': [{'name': 'Medical Director, Endocrinology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen (formerly Tercica)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}