Growth Hormone Deficiency
Conditions
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.
Interventions
DRUGTV-1106
The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.
DRUGdGH
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
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
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with adverse events | 48 weeks | Safety of TV-1106 compared to reference drug |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score | Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48 |
Countries
Austria, Czechia, Greece, Hungary, Italy, Slovakia, Spain, United States
Outcome results
None listed