Expired Study
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Fountain Valley, California


Purpose:

The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.


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


NCT ID:

NCT02410343


Primary Contact:

Study Director
Teva Medical Expert, MD
Teva Pharmaceuticals USA


Backup Contact:

N/A


Location Contact:

Fountain Valley, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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