To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden (ECOS SWE)
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Purpose
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™.
| Condition | Intervention |
|---|---|
|
Growth Disorders |
Device: easypod™ |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | 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 |
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
- 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™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
- Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
- Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
- Correlation of adherence and HbA1C [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 106 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
-
Device: easypod™
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.
Primary Objective:
• To assess the level of adherence of subjects receiving SAIZEN® via Easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
- To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
- To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
Other Objectives:
• To assess the impact of adherence on average blood glucose (HbA1C)
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the Easypod™ electromechanical device.
Inclusion Criteria:
- Administered growth hormone via the EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)
- Over the age of > 2 years old
- Under < 18 years of age, or over 18 years of age without fusion of growth plates
- 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.
Exclusion Criteria:
- Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
- Contra-indications to SAIZEN® as defined in the SmPC
- Use of an investigational drug or participation in an interventional clinical study
Contacts and Locations| Contact: Merck KGaA Communication Center | +49-6151-72-5200 | service@merck.de |
| Sweden | |
| Merck Serono Research Site | Recruiting |
| Göteborg, Sweden | |
| Merck Serono Research Site | Recruiting |
| Solna, Sweden | |
| Merck Serono Research Site | Recruiting |
| Uppsala, Sweden | |
| Study Director: | Medical Responsible | Merck A.B., Sweden |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01307059 History of Changes |
| Other Study ID Numbers: | EMR 200104-524 |
| Study First Received: | March 1, 2011 |
| Last Updated: | August 22, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Merck KGaA:
|
Growth disorders Saizen Easypod Growth hormone Pediatric subject |
Additional relevant MeSH terms:
|
Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013