Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT01307059
Eligibility Criteria:
Inclusion Criteria:
* Administered growth hormone via the EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)
* Over the age of \> 2 years old
* Under \< 18 years of age, or over 18 years of age 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 SmPC
* Use of an investigational drug or participation in an interventional clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01307059
Study Brief:
Protocol Section:
NCT01307059