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 |
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.
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
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