Status:
COMPLETED
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
23-65 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the clinical effect of TV-1106.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01811576
Start Date
March 31 2013
End Date
August 5 2013
Last Update
December 10 2021
Active Locations (23)
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1
Teva Investigational Site 10564
Portland, Oregon, United States, 97239
2
Teva Investigational Site 54052
Hradec Králové, Czechia, 500 05
3
Teva Investigational Site 54051
Olomouc, Czechia, 775 20
4
Teva Investigational Site 32239
Dresden, Germany, 01307