To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Greece
- Conditions
- Growth Disorders
- Registration Number
- NCT01363674
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
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 hospitals in Greece and to assess the level of adherence of subjects 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 identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
* To assess/describe the impact of the Greek Scientific Service (Patient Support Program)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Administered growth hormone (SAIZEN®) via the Easypod™ auto-injector, according to approved Summary of Product Characteristics (SmPC)
- Naïve subjects or already treated with SAIZEN® and Easypod™ for up to 1 year
- Male and female between 2 - 18 years of age, or over 18 without fusion of growth plates
- Parent's or guardian's (or subject's if over 18 without fusion of growth plates) 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.
- Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects)
- Contra-indications to SAIZEN® as defined in the approved 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 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™
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-I status (i.e. above, below or within normal ranges) At least 6 months and up to 5 years Impact of Greek Scientific Service (Patient Support Program) on adherence and outcomes for subjects using Easypod™. At least 6 months and up to 5 years
Trial Locations
- Locations (1)
For Recruiting Locations in Greece,
🇬🇷Please Contact The Merck KGaA Communication Center, Greece