A Phase 2 interventional study of somavaratan in Adult Growth Hormone Deficiency, sponsored by Versartis Inc.. Completed at 18 sites in 4 countries. Open to participants aged 23 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Versartis Inc. · Phase 2, Interventional, and Treatment
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
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.
164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Versartis Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \>= 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \< 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Also known as: VRS-317
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.
Time frame: 5 months
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)
Time frame: 5 months
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)
To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration
Time frame: 5 months
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Time frame: 5 months
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
Time frame: 5 months
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Versartis Inc.