Clinical Trial: Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (dGH) in Adults With Growth
Brief Summary: This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.
Detailed Summary:
Sponsor: Teva Pharmaceutical Industries, Ltd.
Current Primary Outcome: Percentage of participants with adverse events [ Time Frame: 48 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score [ Time Frame: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48 ]
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