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

NCT01402999 | Completed

• 1 other identifier: EMR200104-528
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Hungarian, 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™.

Conditions

Growth Disorders

Keywords

Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject

Outcome Measures

Primary Outcomes (1)

• Mean percent of daily recorded adherence

  At least 6 months and up to 5 years

Secondary Outcomes (3)

• Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™

  At least 6 months and up to 5 years

• 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

Interventions

easypod™ DEVICE

Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™

Also known as: Somatotropin

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.

You may qualify if:

• Administered growth hormone via the easypod™ electromechanical device according to the 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 observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

You may not qualify if:

• 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 SmPC
• Use of an investigational drug or participation in an interventional clinical study

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Kft., Hungary: collaborator

Study Sites (1)

For Recruiting Locations in Hungary

Please Contact the Merck KGaA Communication Center, Hungary

Location

Related Publications (2)

• Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

  RESULT

• Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

  RESULT

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Merck Kft., Hungary

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 27, 2011
• Study Start: May 31, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

HU (1)