MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)

Exclusion Criteria

• •Females who are pregnant or breast-feeding
• •Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months (confirmed by computer tomography (CT) or magnetic resonance imaging (MRI) scan (with contrast) within 3 months prior to study entry or at screening).
• •History of malignancy other than i) cranial irradiation (for cranial tumor or leukemia) causing GHD or ii) fully treated basal cell carcinoma
• •Signs of intracranial hypertension at screening
• •Heart insufficiency, NYHA class greater than 2
• •History of impaired glucose tolerance, insulin resistance or overt diabetes mellitus defined according to the American Diabetes Association (ADA) Criteria
• •Impaired liver function defined as elevation of liver enzymes \>2 x upper limit of normal
• •Impaired kidney function defined as increased serum creatinine levels \>1.5 x upper limit of normal
• •Active acromegaly in the last 18 months and less than 6 months of active r- hGH replacement therapy
• •Active Carpal tunnel syndrome
• •Prader-Willi syndrome
• •Active Cushing's syndrome within the last 12 months
• •Systemic corticosteroids other than in replacement doses within the 3 months before study entry (temporary adjustment of glucocorticoids, as appropriate, is acceptable)
• •Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry
• •History of non-compliance with medications, un-cooperativeness or drug abuse
• •Blood donation or any major blood loss \>500 mL within the past 90 days prior to study entry
• •Patients who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG
• •Patients who participated in any investigational medicinal product (IMP) study within the last 2 months
• •History of positive serology to HBC, HBV and HIV