Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT01243892
Status:
TERMINATED
Last Update Posted:
2016-12-01
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated prematurely due to slow enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately 9 months', 'description': 'Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.', 'eventGroups': [{'id': 'EG000', 'title': 'IGHD Participants', 'description': "IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.", 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ISS Participants', 'description': "ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen.", 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Peripheral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGHD Participants', 'description': "IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'OG001', 'title': 'ISS Participants', 'description': "ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}], 'timeFrame': 'Baseline up to Month 24 (Year 2)', 'description': 'The annualized height velocity (cm per year \\[cm/yr\\]) over 2 years was calculated as: \\[(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)\\] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.'}, {'type': 'SECONDARY', 'title': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGHD Participants', 'description': "IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'OG001', 'title': 'ISS Participants', 'description': "ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}], 'timeFrame': 'Baseline up to Month 12 (Year 1)', 'description': 'The annualized height velocity (cm/yr) after 1 year was calculated as: \\[(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)\\] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.'}, {'type': 'SECONDARY', 'title': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGHD Participants', 'description': "IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'OG001', 'title': 'ISS Participants', 'description': "ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}], 'timeFrame': 'Month 12 to Month 24 (Year 1 to Year 2)', 'description': 'The annualized height velocity (cm/yr) for second year was calculated as: \\[(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)\\] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IGHD Participants', 'description': "Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \\[DNA\\] origin) (recombinant human growth hormone \\[rhGH\\]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'FG001', 'title': 'ISS Participants', 'description': "Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Due to slow enrollment, the study was terminated after screening 33 participants and enrolling only 18 participants, out of 480 planned participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IGHD Participants', 'description': "IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'BG001', 'title': 'ISS Participants', 'description': "ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician's discretion, the study protocol did not enforce or specified any treatment regimen."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.60', 'spread': '2.07', 'groupId': 'BG000'}, {'value': '8.11', 'spread': '2.60', 'groupId': 'BG001'}, {'value': '9.35', 'spread': '2.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study population included all enrolled somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'The study was closed due to the slow enrollment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-07', 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment', 'timeFrame': 'Baseline up to Month 24 (Year 2)', 'description': 'The annualized height velocity (cm per year \\[cm/yr\\]) over 2 years was calculated as: \\[(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)\\] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.'}], 'secondaryOutcomes': [{'measure': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment', 'timeFrame': 'Baseline up to Month 12 (Year 1)', 'description': 'The annualized height velocity (cm/yr) after 1 year was calculated as: \\[(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)\\] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.'}, {'measure': 'Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy', 'timeFrame': 'Month 12 to Month 24 (Year 1 to Year 2)', 'description': 'The annualized height velocity (cm/yr) for second year was calculated as: \\[(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)\\] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.'}]}, 'conditionsModule': {'conditions': ['Growth Hormone Deficiency']}, 'descriptionModule': {'briefSummary': 'This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone \\[rhGH\\]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bone age less than or equal to (\\</=) 8 years (females) or \\</= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment\n* Prepubertal males and females by physical exam\n* Naive to rhGH therapy\n* Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature\n* Height standard deviation score (Ht SDS) \\</= -1.5 (\\</= 5th percentile) for IGHD participants; Ht SDS \\</= -2.25 (\\</= 1.2 percentile) for ISS participants\n\nExclusion Criteria:\n\n* Short stature etiologies other than IGHD or ISS\n* Participants receiving chronic corticosteroid therapy (greater than \\[\\>\\] 3 months) for other medical conditions\n* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated\n* Females with turner syndrome\n* Any previous rhGH treatment\n* Participation in another simultaneous medical investigation or trial\n* Pediatric participants with closed epiphyses\n* Participants prescribed rhGH doses outside the variance of NCGS control participant dosing'}, 'identificationModule': {'nctId': 'NCT01243892', 'briefTitle': 'A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®', 'orgStudyIdInfo': {'id': 'L4917g'}, 'secondaryIdInfos': [{'id': 'ML01311', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: IGHD participants', 'description': "Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \\[DNA\\] origin) (recombinant human growth hormone \\[rhGH\\]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.", 'interventionNames': ['Device: NuSpin', 'Drug: Somatropin']}, {'label': 'Cohort 2: ISS participants', 'description': "Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.", 'interventionNames': ['Device: NuSpin', 'Drug: Somatropin']}], 'interventions': [{'name': 'NuSpin', 'type': 'DEVICE', 'description': 'Device for administration of doses of somatropin.', 'armGroupLabels': ['Cohort 1: IGHD participants', 'Cohort 2: ISS participants']}, {'name': 'Somatropin', 'type': 'DRUG', 'otherNames': ['Nutropin AQ (Somatropin [DNA Origin] injection)'], 'description': 'Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.', 'armGroupLabels': ['Cohort 1: IGHD participants', 'Cohort 2: ISS participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '32905', 'city': 'Palm Bay', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.03446, 'lon': -80.58866}}, {'zip': '33028', 'city': 'Pembrook Pines', 'state': 'Florida', 'country': 'United States'}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60187', 'city': 'Wheaton', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.86614, 'lon': -88.10701}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '10801', 'city': 'New Rochelle', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.91149, 'lon': -73.78235}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'D. Aaron Davis, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}