The primary objective of this study is to evaluate the clinical effect of TV-1106.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Subcutaneous once daily
Teva Investigational Site 10564
Portland, Oregon, United States
Insulin-like growth factor I (IGF-I) concentration change from baseline
Time frame: Baseline to Week 12
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Time frame: Baseline to Week 12
Safety Parameters
The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity.
Time frame: 78 weeks
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Teva Investigational Site 54052
Hradec Králové, Czechia
Teva Investigational Site 54051
Olomouc, Czechia
Teva Investigational Site 32239
Dresden, Germany
Teva Investigational Site 32238
Munich, Germany
Teva Investigational Site 32237
Munich, Germany
Teva Investigational Site 63044
Athens, Greece
Teva Investigational Site 63045
Athens, Greece
Teva Investigational Site 51056
Budapest, Hungary
Teva Investigational Site 51055
Budapest, Hungary
...and 13 more locations