Trials / Terminated
TerminatedNCT02410343
Study of TV-1106 in Growth Hormone-Deficient Adults
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TV-1106 | A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. |
| DRUG | Placebo | Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment. |
Timeline
- Start date
- 2015-04-30
- Primary completion
- 2015-12-31
- Completion
- 2015-12-31
- First posted
- 2015-04-07
- Last updated
- 2022-01-24
- Results posted
- 2018-06-11
Locations
33 sites across 7 countries: United States, Austria, Czechia, Greece, Hungary, Italy, Russia
Source: ClinicalTrials.gov record NCT02410343. Inclusion in this directory is not an endorsement.