A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
- Registration Number
- NCT02092077
- Lead Sponsor
- Teva Pharmaceutical Industries, Ltd.
- Brief Summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TV-1106 0.554 mg TV-1106 - somatropin 0.033 mg/kg/day somatropin Dosages may be adjusted according to findings and as necessary TV-1106 0.924 mg/kg TV-1106 - TV-1106 1.20 mg/kg TV-1106 -
- Primary Outcome Measures
Name Time Method Height velocity (HV) Month 6
- Secondary Outcome Measures
Name Time Method Height velocity standard deviation score (HV-SDS) Months 6 and 12 Height velocity (HV) Month 12 Number of participants with adverse events up to 24 months Height standard deviation score (H-SDS) Months 6 and 12
Trial Locations
- Locations (34)
Teva Investigational Site 68016
🇧🇾Minsk, Belarus
Teva Investigational Site 59060
🇧🇬Varna, Bulgaria
Teva Investigational Site 81022
🇬🇪Tbilisi, Georgia
Teva Investigational Site 81023
🇬🇪Tbilisi, Georgia
Teva Investigational Site 51159
🇭🇺Budapest, Hungary
Teva Investigational Site 80052
🇮🇱Afula, Israel
Teva Investigational Site 80056
🇮🇱Ramat Gan, Israel
Teva Investigational Site 52056
🇷🇴Timisoara, Romania
Teva Investigational Site 50258
🇷🇺Moscow, Russian Federation
Teva Investigational Site 50259
🇷🇺Moscow, Russian Federation
Teva Investigational Site 50260
🇷🇺Kazan, Russian Federation
Teva Investigational Site 50262
🇷🇺Tomsk, Russian Federation
Teva Investigational Site 50263
🇷🇺Saratov, Russian Federation
Teva Investigational Site 50265
🇷🇺Ufa, Russian Federation
Teva Investigational Site 61030
🇷🇸Belgrade, Serbia
Teva Investigational Site 61032
🇷🇸Nis, Serbia
Teva Investigational Site 31099
🇪🇸Girona, Spain
Teva Investigational Site 82011
🇹🇷Ankara, Turkey
Teva Investigational Site 58138
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 58140
🇺🇦Kiev, Ukraine
Teva Investigational Site 58139
🇺🇦Kyiv, Ukraine
Teva Investigational Site 58142
🇺🇦Odessa, Ukraine
Teva Investigational Site 51181
🇭🇺Szombathely, Hungary
Teva Investigational Site 82013
🇹🇷Aydın, Turkey
Teva Investigational Site 81025
🇬🇪Tbilisi, Georgia
Teva Investigational Site 80055
🇮🇱Beer Sheva, Israel
Teva Investigational Site 63046
🇬🇷Athens, Greece
Teva Investigational Site 50261
🇷🇺Izhevsk, Russian Federation
Teva Investigational Site 50268
🇷🇺Samara, Russian Federation
Teva Investigational Site 80053
🇮🇱Petach Tikva, Israel
Teva Investigational Site 53216
🇵🇱Warszawa, Poland
Teva Investigational Site 50267
🇷🇺Saint-Petersburg, Russian Federation
Teva Investigational Site 51160
🇭🇺Budapest, Hungary
Teva Investigational Site 50264
🇷🇺Novosibirsk, Russian Federation