ECOS ITA: To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01439061

Collaborator

Merck Serono S.P.A., Italy (Industry)

220

Enrollment

Location

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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™.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Device: Device: 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)

Study Design

Study Type:

Observational

Actual Enrollment :

220 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy

Actual Study Start Date :

Mar 31, 2012

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2015

Outcome Measures

Primary Outcome Measures

Mean percent of daily recorded adherence [At least 6 months and up to 5 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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 Summary of Product Characteristics (SmPC)
Use of an investigational drug or participation in another interventional clinical study