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 ]

Safety of TV-1106 compared to reference drug


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