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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT02410356
Eligibility Criteria:
Inclusion Criteria:
* males and females 18 years of age or over
* diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
* treated with a stable dose of daily rhGH for at least 3 months prior to screening
* stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
* Other criteria apply, please contact the investigator for more information
Exclusion Criteria:
* patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
* Presence of contraindications to rhGH treatment
* patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
* patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year
* patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
* presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.
* patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%
* patients using weight reducing agents or appetite suppressants
* Other criteria apply, please contact the investigator for more information
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02410356
Study Brief:
Protocol Section:
NCT02410356