Brief Title
Study of TV-1106 in Growth Hormone-Deficient Adults
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
Brief Summary
The primary objective of this study is to determine the efficacy of 6 months of treatment
with TV-1106 compared with placebo on body fat composition.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period
Secondary Outcome
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period
Condition
Growth Hormone Deficiency
Intervention
TV-1106
Study Arms / Comparison Groups
Placebo
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
14
Start Date
April 30, 2015
Completion Date
December 31, 2015
Primary Completion Date
December 31, 2015
Eligibility Criteria
Inclusion:
- males and females 18 years of age or over
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Teva Medical Expert, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02410343
Organization ID
TV1106-IMM-30021
Secondary IDs
2014-003796-32
Responsible Party
Sponsor
Study Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Study Sponsor
Teva Medical Expert, MD, Study Director, Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date
January 2022