Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
14 participants
INTERVENTIONAL
2015-04-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
NCT02410356
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
NCT01811576
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
NCT02092077
Treatment of Adults With Growth Hormone Deficiency
NCT00294619
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
NCT00006394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration.
Placebo
Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
TV-1106
TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
TV-1106
A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TV-1106
A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
Placebo
Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
* no history of exposure to any rhGH within the past 12 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:
* 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)
* 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 1 year
* patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8%
* patients using weight reducing agents or appetite suppressants
* women who are pregnant or nursing, or planning pregnancy during the study period
* Other criteria apply, please contact the investigator for more information
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teva Investigational Site 13102
Artesia, California, United States
Teva Investigational Site 13127
Fountain Valley, California, United States
Teva Investigational Site 13126
Fountain Valley, California, United States
Teva Investigational Site 13103
Miami, Florida, United States
Teva Investigational Site 13118
Miami, Florida, United States
Teva Investigational Site 13123
Miami, Florida, United States
Teva Investigational Site 13492
Miami, Florida, United States
Teva Investigational Site 13114
Miami Lakes, Florida, United States
Teva Investigational Site 13100
Pembroke Pines, Florida, United States
Teva Investigational Site 13121
West Palm Beach, Florida, United States
Teva Investigational Site 13104
Chicago, Illinois, United States
Teva Investigational Site 13124
Evansville, Indiana, United States
Teva Investigational Site 13101
Detroit, Michigan, United States
Teva Investigational Site 13112
Henderson, Nevada, United States
Teva Investigational Site 13113
Las Vegas, Nevada, United States
Teva Investigational Site 13109
Brooklyn, New York, United States
Teva Investigational Site 13494
New York, New York, United States
Teva Investigational Site 13106
New York, New York, United States
Teva Investigational Site 13096
Asheville, North Carolina, United States
Teva Investigational Site 13108
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 13110
Arlington, Texas, United States
Teva Investigational Site 13125
Dallas, Texas, United States
Teva Investigational Site 13097
Houston, Texas, United States
Teva Investigational Site 13107
Houston, Texas, United States
Teva Investigational Site 13120
Houston, Texas, United States
Teva Investigational Site 33030
Linz, , Austria
Teva Investigational Site 54112
Moravskoslezsky, , Czechia
Teva Investigational Site 63054
Athens, , Greece
Teva Investigational Site 63053
Chaïdári, , Greece
Teva Investigational Site 51197
Budapest, , Hungary
Teva Investigational Site 51195
Pécs, , Hungary
Teva Investigational Site 30112
Brescia, , Italy
Teva Investigational Site 50303
Saint Petersburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-003796-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV1106-IMM-30021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.