Clinical Trial: Study of TV-1106 in Growth Hormone-Deficient Adults
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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.
Detailed Summary:
Sponsor: Teva Pharmaceutical Industries, Ltd.
Current Primary Outcome: Change from baseline to week 24 in body fat mass (kg) as measured by dual-energy x-ray absorptiometry (DXA) [ Time Frame: Baseline, weeks 12 and 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline to week 24 in total trunk fat (kg) as measured by DXA [ Time Frame: Baseline, weeks 12 and 24 ]
- Change in insulin-like growth factor 1 standard deviation score from baseline to week 24 [ Time Frame: Screening, baseline, weeks 4, 8, 12, 16, 24 ]
- Change from baseline in Quality of Life scores [ Time Frame: Baseline, week 24 ]Assessment of growth hormone deficient adults questionnaire
- Percentage of participants with adverse events [ Time Frame: 24 Weeks ]
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: March 30, 2015
Date Started: April 2015
Date Completion:
Last Updated: April 26, 2016
Last Verified: April 2016
