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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01947894
Eligibility Criteria:
Inclusion Criteria:
* Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
1. Newly diagnosed with GHD according to the current medical standard.
2. Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
3. Transition patients diagnosed with CO-GHD before 2013.
* Prescribed Genotropin at the time of inclusion.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
* Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01947894
Study Brief:
Protocol Section:
NCT01947894