Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT01291394
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France
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': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent of recorded adherence', 'timeFrame': 'At least 6 months and up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of adherence and growth outcome (change in height velocity (HV), change in HV-Standard Deviation Score (HV-SDS), change in height-Standard Deviation Score) after each year of Saizen® treatment with Easypod™', 'timeFrame': 'At least 6 months and up to 5 years'}, {'measure': 'Subject adherence profile', 'timeFrame': 'At least 6 months and up to 5 years', 'description': 'Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment, administration regimen (6 or 7 days/ week), combination of pituitary hormone deficiencies, previous and/or concomitant treatments, socio-economic data'}, {'measure': 'Correlation of adherence with IGF-1 levels/ranges', 'timeFrame': 'At least 6 months and up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, '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 a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.', 'detailedDescription': "Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.\n\nEasypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \\& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.\n\nSince this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device 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) ranges/levels"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who are taking SAIZEN® for a pediatric registered indications using the Easypod™ electromechanical device.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Administered Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).\n* Naïve subjects or already treated with Saizen and Easypod for maximum 1 year\n* Male and Female between 2 - 18 years of age, or over 18 without fusion of growth plates\n* Parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n* Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)\n* Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (SmPC)\n* Use of an investigational drug or participation in an interventional clinical study"}, 'identificationModule': {'nctId': 'NCT01291394', 'acronym': 'ECOS FRA', 'briefTitle': 'To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment', 'orgStudyIdInfo': {'id': 'EMR 200104-515'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Easypod™', 'type': 'DEVICE', 'otherNames': ['Somatotropin'], 'description': 'Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Communication Center', 'country': 'France', 'facility': 'Contact Merck KGaA'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono S.A.S, France', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}