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Growth Disorders

Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic

Sponsored by Merck KGaA, Darmstadt, Germany

About this trial

Last updated 7 years ago

Study ID

EMR200104-527

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
2 to 18 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

This is 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™.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

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 SmPC

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