Study of TV-1106 in Growth Hormone-Deficient Adults



Status:Terminated
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:7/11/2018
Start Date:April 2015
End Date:December 2015

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety, and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment

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.


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
We found this trial at
27
sites
Evansville, Indiana
?
mi
from 91732
Evansville, IN
Click here to add this to my saved trials
?
mi
from 91732
Arlington, TX
Click here to add this to my saved trials
Artesia, California
14
mi
from 91732
Artesia, CA
Click here to add this to my saved trials
Asheville, North Carolina
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
Brooklyn, New York
2436
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Chicago, Illinois
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
5876
mi
from 91732
Cordoba,
Click here to add this to my saved trials
1224
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
Fountain Valley, California
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Fountain Valley, California
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
218
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
Houston, Texas 77054
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77054
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77054
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77054
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Las Vegas, Nevada
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida
2311
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
New York, New York
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
New York, New York
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
Pembroke Pines, Florida
2308
mi
from 91732
Pembroke Pines, FL
Click here to add this to my saved trials
Pittsburgh, Pennsylvania
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
West Palm Beach, Florida
2304
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials