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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01263457
Eligibility Criteria:
Inclusion Criteria:
* Administered growth hormone via the easypod electromechanical injection 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 (to be confirmed by the Investigator, where relevant)
* Appropriate Informed Consent/Assent provided
Exclusion Criteria:
* Patients 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 or any other condition which precludes the use of SAIZEN in a given patient
* Use of an investigational drug or participation in an interventional clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01263457
Study Brief:
Protocol Section:
NCT01263457