Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
- Registration Number
- NCT02410356
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TV-1106 TV-1106 TV-1106 to be injected once weekly. dGH dGH dGH to be given as daily injections.
- Primary Outcome Measures
Name Time Method Percentage of participants with adverse events 48 weeks Safety of TV-1106 compared to reference drug
- Secondary Outcome Measures
Name Time Method Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
Trial Locations
- Locations (50)
Teva Investigational Site 13166
🇺🇸Fountain Valley, California, United States
Teva Investigational Site 13142
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 13144
🇺🇸Arlington, Texas, United States
Teva Investigational Site 13137
🇺🇸Artesia, California, United States
Teva Investigational Site 13129
🇺🇸West Palm Beach, Florida, United States
Teva Investigational Site 54119
🇨🇿Moravskoslezsky, Czechia
Teva Investigational Site 13138
🇺🇸Miami, Florida, United States
Teva Investigational Site 13161
🇺🇸Miami, Florida, United States
Teva Investigational Site 13500
🇺🇸Miami, Florida, United States
Teva Investigational Site 13147
🇺🇸Las Vegas, Nevada, United States
Teva Investigational Site 13130
🇺🇸Houston, Texas, United States
Teva Investigational Site 13154
🇺🇸Houston, Texas, United States
Teva Investigational Site 13164
🇺🇸Seattle, Washington, United States
Teva Investigational Site 13135
🇺🇸Detroit, Michigan, United States
Teva Investigational Site 13158
🇺🇸Newark, Delaware, United States
Teva Investigational Site 13162
🇺🇸Fort Lauderdale, Florida, United States
Teva Investigational Site 13165
🇺🇸Lakewood, California, United States
Teva Investigational Site 13136
🇺🇸Homestead, Florida, United States
Teva Investigational Site 13152
🇺🇸Miami, Florida, United States
Teva Investigational Site 13134
🇺🇸Pembroke Pines, Florida, United States
Teva Investigational Site 13503
🇺🇸Miami, Florida, United States
Teva Investigational Site 13502
🇺🇸New York, New York, United States
Teva Investigational Site 13140
🇺🇸New York, New York, United States
Teva Investigational Site 13146
🇺🇸Henderson, Nevada, United States
Teva Investigational Site 13143
🇺🇸Brooklyn, New York, United States
Teva Investigational Site 13128
🇺🇸Asheville, North Carolina, United States
Teva Investigational Site 13163
🇺🇸Dallas, Texas, United States
Teva Investigational Site 13141
🇺🇸Houston, Texas, United States
Teva Investigational Site 33035
🇦🇹Linz, Austria
Teva Investigational Site 13159
🇺🇸Norfolk, Virginia, United States
Teva Investigational Site 13504
🇺🇸Federal Way, Washington, United States
Teva Investigational Site 13157
🇺🇸Tacoma, Washington, United States
Teva Investigational Site 54118
🇨🇿Brno, Czechia
Teva Investigational Site 54116
🇨🇿Plzensky, Czechia
Teva Investigational Site 63059
🇬🇷Athens, Greece
Teva Investigational Site 51206
🇭🇺Budapest, Hungary
Teva Investigational Site 63058
🇬🇷Chaidari, Greece
Teva Investigational Site 63060
🇬🇷Ioannina, Greece
Teva Investigational Site 51202
🇭🇺Budapest, Hungary
Teva Investigational Site 51208
🇭🇺Szeged, Hungary
Teva Investigational Site 51204
🇭🇺Pecs, Hungary
Teva Investigational Site 51205
🇭🇺Debrecen, Hungary
Teva Investigational Site 51207
🇭🇺Szolnok, Hungary
Teva Investigational Site 31121
🇪🇸Cordoba, Spain
Teva Investigational Site 30129
🇮🇹Brescia, Italy
Teva Investigational Site 31125
🇪🇸Madrid, Spain
Teva Investigational Site 62041
🇸🇰Lubochna, Slovakia
Teva Investigational Site 31129
🇪🇸Badalona, Spain
Teva Investigational Site 13148
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 13155
🇺🇸Denver, Colorado, United States