Clinical Trial: Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With
Brief Summary: The primary objective of this study is to evaluate the clinical effect of TV-1106.
Detailed Summary:
Sponsor: Teva Pharmaceutical Industries
Current Primary Outcome: Insulin-like growth factor I (IGF-I) concentration change from baseline [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS [ Time Frame: Baseline to Week 12 ]
- Safety Parameters [ Time Frame: 78 weeks ]The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity.
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: March 12, 2013
Date Started: March 2013
Date Completion:
Last Updated: February 26, 2016
Last Verified: February 2016
