To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in South Korea

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT01259778
• Date of registration: 13/12/2010
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in South Korea ECOS KOR
• Scientific title: Easypod Connect: 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
• Date of first enrolment: February 28, 2011
• Target sample size: 224
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01259778
• Study type: Observational
• Phase: N/A

Countries of recruitment

Korea, Republic of

Contacts

• Name: Medical Responsible
• Affiliation: Merck KGaA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Administered growth hormone via the easypod™ electromechanical device according to
Summary of Product Characteristics (SmPC)

- Over the age of >2 years

- Under <18 years of age, or over 18 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 Summary of Product Characteristics
(SmPC)

- Use of an investigational drug or participation in an interventional clinical study



Age minimum: 2 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Disorders

Primary Outcome(s)

Mean percent of adherence by subject over a period of time [Time Frame: At least 6 months and up to 5 years]

Secondary Outcome(s)

Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height standard deviation score) after each year of SAIZEN® treatment with easypod™ [Time Frame: At least 6 months and up to 5 years]

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]

Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™ [Time Frame: At least 6 months and up to 5 years]

Secondary ID(s)

EMR 200104-522

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Ltd.