Trials / Terminated
TerminatedNCT02410356
Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TV-1106 | The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range. |
| DRUG | dGH | The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study. |
Timeline
- Start date
- 2015-04-30
- Primary completion
- 2016-02-29
- Completion
- 2016-04-30
- First posted
- 2015-04-07
- Last updated
- 2021-12-10
Locations
50 sites across 8 countries: United States, Austria, Czechia, Greece, Hungary, Italy, Slovakia, Spain
Source: ClinicalTrials.gov record NCT02410356. Inclusion in this directory is not an endorsement.