Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Growth hormone deficient men and women ages 18-60 years with a hypothalamic and/or pituitary structural lesion or longstanding idiopathic GHD

Growth hormone deficiency as determined by pituitary testing within the last five years by either of the two following tests:

Insulin hypoglycemia (glucose < 50 mg/dL) with maximum GH < 5 ng/mL (5 µg/L) by radioimmunoassay or < 2.5 µg/L, if measured by immunoradiometric assay
Arginine-GHRH infusions with maximum GH < 5 ng/mL (5 µg/L) or < 2.5 µg/L, if measured by immunoradiometric assay
Women must be of non-child bearing potential (hysterectomy, tubal ligation, or IUD are acceptable) during the three months prior to entering the study, or post-menopausal (no menses for one year or more), or six to twelve months without menses and β-estradiol levels < 20 pg/mL
Glucocorticoid use is allowed provided the subject has been on physiologic (<7.5 mg prednisone or equivalent/day) replacement doses for at least 3 months
Free thyroxine (T4) within the normal range at Screening. If the subject is receiving thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks prior to Screening
Willing and able to provide written informed consent
BMI 20 - 36 kg/m2

Exclusion Criteria:

Any previous or ongoing clinically significant illness that, in the opinion of the investigator, could prevent the subject from completing the study
Any history of cancer within the past 5 years, except for dermal squamous and basal cell carcinoma with documented 6-month remission. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission
BMI <20 or >36 kg/m2
Any allergic or abnormal reaction to human growth hormone
Inability of the subject to discontinue use of their regularly prescribed human growth hormone treatment from six weeks prior to Day -1 through the completion of the study
Serum creatinine > 1.4 mg/dL
Hypocalcemia or hypercalcemia from any cause
Hyperparathyroidism, osteomalacia or any other disorder which may affect bone and bone markers including the use of bisphosphonates or other medications for osteoporosis
Participation in another clinical trial 30 days prior to screening
Demonstrated inability to comply with protocol requirements (e.g. uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance, and/or poor likelihood of completing the study)
Blood donation within 56 days of the screening visit
Plasma donation within seven days of the screening visit
Positive serum pregnancy test
Women of child bearing potential
Abuse of alcohol; to be determined by principal investigator
Abuse of prescription or illicit drugs; to be determined by principal investigator