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



Status:Active, not recruiting
Conditions:Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:April 2016

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A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (dGH) in Adults With Growth Hormone-Deficiency

This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in
adults with GHD who have previously been treated with rhGH.


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
We found this trial at
35
sites
Fountain Valley, California
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Fountain Valley, CA
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Arlington, TX
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Artesia, California
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Artesia, CA
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Asheville, North Carolina
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Asheville, NC
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Brooklyn, New York
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Brooklyn, NY
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Ciudad de Buenos Aires,
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Ciudad de Buenos Aires,
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Dallas, TX
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Denver, CO
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Detroit, Michigan
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Detroit, MI
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Federal Way, Washington
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Federal Way, WA
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Henderson, NV
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Hollywood, Florida
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Hollywood, FL
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Homestead, Florida
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Homestead, FL
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Houston, Texas 77054
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Houston, TX
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Houston, Texas 77054
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Houston, TX
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Houston, Texas 77054
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Houston, TX
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Houston, Texas 77054
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Houston, TX
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Lakewood, California
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Lakewood, CA
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Las Vegas, Nevada
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Las Vegas, NV
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Miami, FL
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Miami, FL
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Miami, FL
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Miami, FL
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Miami, FL
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Miami Lakes, Florida
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Miami Lakes, FL
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New York, New York
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New York, NY
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New York, New York
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New York, NY
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Newark, Delaware
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Newark, DE
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Norfolk, Virginia
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Norfolk, VA
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Pembroke Pines, Florida
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Pembroke Pines, FL
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Pittsburg, Pennsylvania
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Pittsburg, PA
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Portland, Oregon
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Portland, OR
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Portland, Oregon
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Portland, OR
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Tacoma, Washington
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Tacoma, WA
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West Palm Beach, Florida
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West Palm Beach, FL
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