Trials / Completed
CompletedNCT02526420
Versartis International Trial in Adults With Long-Acting Growth Hormone
An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Versartis Inc. · Industry
- Sex
- All
- Age
- 23 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
Detailed description
A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | somavaratan | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2015-08-18
- Last updated
- 2022-07-26
Locations
18 sites across 4 countries: United States, Australia, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT02526420. Inclusion in this directory is not an endorsement.