Study of TV-1106 in Growth Hormone-Deficient Adults

Inclusion Criteria

• •Inclusion:
• •males and females 18 years of age or over
• •diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
• •no history of exposure to any rhGH within the past 12 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:
• •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)
• •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 1 year
• •patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8%
• •patients using weight reducing agents or appetite suppressants
• •women who are pregnant or nursing, or planning pregnancy during the study period
• •* Other criteria apply, please contact the investigator for more information