Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
NCT ID: NCT01811576
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2013-03-31
2013-08-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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recombinant human growth hormone
Daily subcutaneous dose
Recombinant human growth hormone
Subcutaneous once daily
TV-1106
Titration dose levels of TV-1106
TV-1106
Interventions
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TV-1106
Recombinant human growth hormone
Subcutaneous once daily
Eligibility Criteria
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Inclusion Criteria
* 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 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.
23 Years
65 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Locations
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Teva Investigational Site 10564
Portland, Oregon, United States
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
Teva Investigational Site 51060
Debrecen, , Hungary
Teva Investigational Site 51061
Győr, , Hungary
Teva Investigational Site 51059
Pécs, , Hungary
Teva Investigational Site 51057
Szeged, , Hungary
Teva Investigational Site 51058
Szolnok, , Hungary
Teva Investigational Site 80033
Jerusalem, , Israel
Teva Investigational Site 80032
Petah Tikva, , Israel
Teva Investigational Site 80034
Tel Aviv, , Israel
Teva Investigational Site 61029
Belgrade, , Serbia
Teva Investigational Site 62017
Bratislava, , Slovakia
Teva Investigational Site 62022
Bratislava, , Slovakia
Teva Investigational Site 62016
Ľubochňa, , Slovakia
Teva Investigational Site 64016
Ljubljana, , Slovenia
Countries
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Other Identifiers
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2012-004975-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV1106-GHD-201
Identifier Type: -
Identifier Source: org_study_id