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

Sponsored by Merck KGaA, Darmstadt, Germany

About this trial

Last updated 8 years ago

Study ID

EMR 200104-534

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 10 years ago

What is this trial about?

This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and 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 Summary of Product Characteristic (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. 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

No

Exclusion Criteria

- Subjects taking growth hormone in whom growth plates have fused (that is, 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 another interventional clinical study

Locations

Location

Status