Growth Hormone Deficiency
Conditions
Keywords
Growth hormone deficiency, Insulin-like growth factor I (IGF-I), TV-1106
Brief summary
The primary objective of this study is to evaluate the clinical effect of TV-1106.
Interventions
DRUGTV-1106
DRUGRecombinant human growth hormone
Subcutaneous once daily
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator. * Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes. * Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing. * Patients should have been treated with a stable dose of daily rhGH for at least 3 months prior to screening. * Other criteria apply.
Exclusion criteria
* Patients with history or clinical evidence of active or chronic diseases that could confound results of the study or put the subject at undue risk as determined by the investigator. * Patients with known active malignancy * Patients with history of malignancy other than intracranial tumor causing GHD (excluding surgically cured basal cell or squamous cell cancer of the skin with documented 6 month remission) * Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3) * Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data to document tumor stability within the 12 months prior to enrollment, which is on day 0 (baseline, Visit 3) * 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. * Other criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin-like growth factor I (IGF-I) concentration change from baseline | Baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS | Baseline to Week 12 | — |
| Safety Parameters | 78 weeks | 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. |
Countries
Czechia, Germany, Greece, Hungary, Israel, Serbia, Slovakia, Slovenia, United States
Outcome results
None listed