Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 1:36 PM
Study NCT ID:
NCT01263457
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2010-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
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': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2010-12-17', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent of adherence by subject over a period of time', 'timeFrame': 'At least 6 months and up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (height SDS) after each year of SAIZEN® treatment with easypod™', 'timeFrame': 'At least 6 months and up to 5 years'}, {'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': 'Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™', 'timeFrame': 'At least 6 months and up to 5 years'}]}, 'conditionsModule': {'keywords': ['Growth disorders', 'Saizen', 'EasypodTM', '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 hospital in the UK and to assess the level of adherence of subject receiving SAIZEN® via Easypod™.', 'detailedDescription': 'Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence 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 explore the hypothesis that patient adherence support programs improve adherence 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 assess the impact of adherence on Insulin-like Growth Factor 1 (IGF-1) (i.e. above, below or within normal ranges)\n* To assess the endocrinological profile including Triiodothyronine (T3), Thyroxine (T4), Thyroid-stimulating hormone (TSH), Insulin-like Growth Factor 1 (IGF-1) and Insulin-like Growth Factor-Binding Protein 3(IGFBP-3) levels\n* Temporal profile of IGF-1 and IGFBP-3 levels'}, '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* Administered growth hormone via the easypod electromechanical injection device according to Summary of Product Characteristics (SmPC)\n* Over the age of 2 years\n* Under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the Investigator, where relevant)\n* Appropriate Informed Consent/Assent provided\n\nExclusion Criteria:\n\n* Patients 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 SmPC or any other condition which precludes the use of SAIZEN in a given patient\n* Use of an investigational drug or participation in an interventional clinical trial"}, 'identificationModule': {'nctId': 'NCT01263457', 'acronym': 'ECOS UK', 'briefTitle': 'To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK', '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 200104-516'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Easypod', 'type': 'DEVICE', 'otherNames': ['Saizen', 'Somatropin'], 'description': 'Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'WC1N 1EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono Limited, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono Limited, UK', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}