Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-18 @ 12:57 AM
Study NCT ID:
NCT01439061
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2011-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-09-21', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent of daily recorded adherence', 'timeFrame': 'At least 6 months and up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™', 'timeFrame': 'At least 6 months and up to 5 years', 'description': 'Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS)) after each year of SAIZEN® treatment with easypod™'}, {'measure': 'Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment', 'timeFrame': 'At least 6 months and up to 5 years'}, {'measure': 'Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)', 'timeFrame': 'At least 6 months and up to 5 years'}]}, 'conditionsModule': {'keywords': ['Growth disorders', 'Saizen', 'Easypod', 'Growth hormone', 'Pediatric subject'], 'conditions': ['Growth Disorders']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.'}, {'type': 'RESULT', 'citation': 'Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.'}]}, 'descriptionModule': {'briefSummary': 'This is an Italian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.', 'detailedDescription': 'Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.\n\nPrimary Objective:\n\n• To assess the level of adherence of subjects receiving SAIZEN® via easypod™\n\nSecondary Objectives:\n\n* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™\n* To identify adherence subject profiling\n* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over the age of \\>2 years\n* Under \\<18 years of age, or over 18 without fusion of growth plates\n* Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given\n\nExclusion Criteria:\n\n* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)\n* Contra-indications to SAIZEN® as defined in the Summary of Product Characteristics (SmPC)\n* Use of an investigational drug or participation in another interventional clinical study"}, 'identificationModule': {'nctId': 'NCT01439061', 'acronym': 'ECOS ITA', 'briefTitle': 'To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy', 'orgStudyIdInfo': {'id': 'EMR200104-529'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Device: easypod™', 'type': 'DEVICE', 'otherNames': ['Somatotropin'], 'description': 'Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Please Contact the Merck KGaA Communication Center', 'country': 'Italy', 'facility': 'For Locations in Italy'}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono S.P.A., Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono S.P.A., Italy', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}