To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia
- Conditions
- Growth Disorders
- Registration Number
- NCT01309555
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
This is an Australian, 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™.
- Detailed Description
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.
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) (above, below or within normal ranges)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Administered growth hormone via the easypod™ electromechanical device according to the SAIZEN® Product Information
- Aged between 2 and 18 years
- Appropriate Informed Consent/Assent provided
- Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
- Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
- Use of an investigational drug or participation in another interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percent of adherence by subject At least 6 months and up to 5 years
- Secondary Outcome Measures
Name Time Method Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ At least 6 months and up to 5 years 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™
Correlation of adherence with current IGF-I status (i.e. above, below or within normal ranges) At least 6 months and up to 5 years Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment with easypod™ At least 6 months and up to 5 years
Trial Locations
- Locations (1)
For Recruiting Locations in Australia
🇦🇺Please Contact The Merck KGaA Communication Center, Australia