At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
Somavaratan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency
In Brief
A Phase 3 clinical trial evaluating Somavaratan and rhGH for Growth Disorders. Completed, enrolled 138 participants.
Detailed Summary
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Disorders
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartAug 2015
Primary CompletionAug 2017
TodayJul 2026
First PostedJan 15, 2015
Enrollment StartAug 26, 2015
Primary CompletionAug 23, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.5 years ago
Interventions
Somavaratandrug
Somavaratan will be administered per dose and schedule specified in the arm description.
rhGHdrug
rhGH will be administered per dose and schedule specified in the arm description.