Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 1:02 PM
Study NCT ID:
NCT01307059
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2011-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden
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': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2011-03-01', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-02', '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 (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™', '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': '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'}, {'measure': 'Correlation of adherence and HbA1C', '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 Swedish, Multicentre, Observational Registry 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 registry. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based 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 based on age, gender, self injection or not, time on treatment, medical history at time of enrollment\n* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)\n\nOther Objectives:\n\n• To assess the impact of adherence on average blood glucose (HbA1C)'}, '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 EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)\n* Over the age of \\> 2 years old\n* Under \\< 18 years of age, or over 18 years of age without fusion of growth plates\n* Parent's or guardian's written informed consent, given before entering data into the registry , with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.\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 SmPC\n* Use of an investigational drug or participation in an interventional clinical study"}, 'identificationModule': {'nctId': 'NCT01307059', 'acronym': 'ECOS SWE', 'briefTitle': 'To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Easypod Connect: A Swedish, 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 200104-524'}}, 'armsInterventionsModule': {'interventions': [{'name': 'easypod™', 'type': 'DEVICE', 'otherNames': ['Somatotropin'], 'description': 'Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Merck Serono Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Solna', 'country': 'Sweden', 'facility': 'Merck Serono Research Site', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Merck Serono Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck A.B., Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck A.B., Sweden', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}