Trials / Terminated
TerminatedNCT02092077
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
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, Growth Hormone-Deficient Children
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Teva Pharmaceutical Industries, Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TV-1106 | TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg |
| DRUG | somatropin | Dose may be adjusted as required |
Timeline
- Start date
- 2014-04-30
- Primary completion
- 2016-04-30
- Completion
- 2016-08-31
- First posted
- 2014-03-19
- Last updated
- 2021-11-09
Locations
34 sites across 13 countries: Belarus, Bulgaria, Georgia, Greece, Hungary, Israel, Poland, Romania, Russia, Serbia, Spain, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT02092077. Inclusion in this directory is not an endorsement.