Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Apr 1, 2015

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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