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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01157793
Eligibility Criteria:
Inclusion Criteria:
* Subjects with diagnosis of childhood onset GH deficiency and previously treated with GH
* Subjects who had attained final height
* Male or female subjects, aged between 14 and 25 years of age inclusively at baseline
* Subjects with GH deficiency of \<5μg/L (acquired or idiopathic), established by any 1 type of GH secretion test within 3 years prior to Study Day 1
* If hypopituitary, subject must have been on adequate replacement therapy (if required) of glucocorticosteroids, thyroid \& sex hormones (hormones levels on replacement being in normal/mildly elevated range) for at least 6 months prior to study entry
* Subjects who were willing and able to comply with the protocol for the duration of the study.
* Subjects who had given written informed consent before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject might withdraw consent at any time without prejudice to future medical care
* Female subjects must be neither pregnant nor breast-feeding, and use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Confirmation that a female subject was not pregnant was established by a negative urinary human chorionic gonadotropin (hCG) pregnancy test at baseline.
Exclusion Criteria:
* Subject who had a known allergy or hypersensitivity to growth hormone or diluent
* Subject who had been treated with r-hGH in previous six months
* Subject with chronic severe kidney disease
* Subject with chronic severe liver disease
* Subject with acute or severe illness during the previous 6 months
* Subject with significant concomitant illness which would interfere with his/her participation or assessment in this study
* Subject with active malignancy (except non-melanomatous skin malignancies)
* Subjects with unstable hypertension (supine systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg)
* Subjects with benign cranial hypertension
* Subjects with a history of carpal tunnel syndrome, unless surgically released
* Subjects with known positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) and/or Hepatitis C virus (HCV) serology based on past medical history
* Subjects with known active drug addiction, including alcoholism, or use of drugs for nontherapeutic purposes
* Subject who had previously participated in this study
* Subject taking an investigational drug or enrolled in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
25 Years
Study:
NCT01157793
Study Brief:
Protocol Section:
NCT01157793