Clinical Trial: A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Grow
Brief Summary: The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
Detailed Summary:
Sponsor: Teva Pharmaceutical Industries
Current Primary Outcome: Height velocity (HV) [ Time Frame: Month 6 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Height velocity standard deviation score (HV-SDS) [ Time Frame: Months 6 and 12 ]
- Height standard deviation score (H-SDS) [ Time Frame: Months 6 and 12 ]
- Number of participants with adverse events [ Time Frame: up to 24 months ]
- Height velocity (HV) [ Time Frame: Month 12 ]
Original Secondary Outcome: Same as current
Information By: Teva Pharmaceutical Industries
Dates:
Date Received: March 14, 2014
Date Started: April 2014
Date Completion:
Last Updated: August 22, 2016
Last Verified: August 2016
