Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
NCT ID: NCT02410356
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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TERMINATED
PHASE3
34 participants
INTERVENTIONAL
2015-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TV-1106
TV-1106 to be injected once weekly.
TV-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.
dGH
dGH to be given as daily injections.
dGH
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
Interventions
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TV-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.
dGH
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 13137
Artesia, California, United States
Teva Investigational Site 13166
Fountain Valley, California, United States
Teva Investigational Site 13165
Lakewood, California, United States
Teva Investigational Site 13155
Denver, Colorado, United States
Teva Investigational Site 13158
Newark, Delaware, United States
Teva Investigational Site 13162
Fort Lauderdale, Florida, United States
Teva Investigational Site 13136
Homestead, Florida, United States
Teva Investigational Site 13138
Miami, Florida, United States
Teva Investigational Site 13152
Miami, Florida, United States
Teva Investigational Site 13161
Miami, Florida, United States
Teva Investigational Site 13500
Miami, Florida, United States
Teva Investigational Site 13503
Miami, Florida, United States
Teva Investigational Site 13148
Miami Lakes, Florida, United States
Teva Investigational Site 13134
Pembroke Pines, Florida, United States
Teva Investigational Site 13129
West Palm Beach, Florida, United States
Teva Investigational Site 13135
Detroit, Michigan, United States
Teva Investigational Site 13146
Henderson, Nevada, United States
Teva Investigational Site 13147
Las Vegas, Nevada, United States
Teva Investigational Site 13143
Brooklyn, New York, United States
Teva Investigational Site 13502
New York, New York, United States
Teva Investigational Site 13140
New York, New York, United States
Teva Investigational Site 13128
Asheville, North Carolina, United States
Teva Investigational Site 13142
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 13144
Arlington, Texas, United States
Teva Investigational Site 13163
Dallas, Texas, United States
Teva Investigational Site 13130
Houston, Texas, United States
Teva Investigational Site 13141
Houston, Texas, United States
Teva Investigational Site 13154
Houston, Texas, United States
Teva Investigational Site 13159
Norfolk, Virginia, United States
Teva Investigational Site 13504
Federal Way, Washington, United States
Teva Investigational Site 13164
Seattle, Washington, United States
Teva Investigational Site 13157
Tacoma, Washington, United States
Teva Investigational Site 33035
Linz, , Austria
Teva Investigational Site 54118
Brno, , Czechia
Teva Investigational Site 54119
Moravskoslezsky, , Czechia
Teva Investigational Site 54116
Plzensky, , Czechia
Teva Investigational Site 63059
Athens, , Greece
Teva Investigational Site 63058
Chaïdári, , Greece
Teva Investigational Site 63060
Ioannina, , Greece
Teva Investigational Site 51202
Budapest, , Hungary
Teva Investigational Site 51206
Budapest, , Hungary
Teva Investigational Site 51205
Debrecen, , Hungary
Teva Investigational Site 51204
Pécs, , Hungary
Teva Investigational Site 51208
Szeged, , Hungary
Teva Investigational Site 51207
Szolnok, , Hungary
Teva Investigational Site 30129
Brescia, , Italy
Teva Investigational Site 62041
Ľubochňa, , Slovakia
Teva Investigational Site 31129
Badalona, , Spain
Teva Investigational Site 31121
Córdoba, , Spain
Teva Investigational Site 31125
Madrid, , Spain
Countries
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Other Identifiers
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TV1106-IMM-30022
Identifier Type: -
Identifier Source: org_study_id