drugset / Trial / NCT01718041

Versartis Trial in Children to Assess Long-Acting Growth Hormone

NCT01718041

Phase 1/2 Completed 64 enrolled Versartis Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.

Timeline

Start
2012-10
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Somavaratan Protein / enzyme biologic Subcutaneous

Indications