To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
- Conditions
- Growth Disorders
- Registration Number
- NCT01439061
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
This is an Italian, Multicentre, Observational Study 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 study. Parents or guardian and subjects (when applicable) will provide their Informed Consent to upload their data for population-based analyses 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 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
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Over the age of >2 years
- Under <18 years of age, or over 18 without fusion of growth plates
- Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given
- 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 Summary of Product Characteristics (SmPC)
- Use of an investigational drug or participation in another interventional clinical study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percent of daily recorded adherence 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 (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™
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment At least 6 months and up to 5 years Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) At least 6 months and up to 5 years
Trial Locations
- Locations (1)
For Locations in Italy
🇮🇹Please Contact The Merck KGaA Communication Center, Italy