drugset / Trial / NCT01718041
Versartis Trial in Children to Assess Long-Acting Growth Hormone
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somavaratan | Protein / enzyme biologic | — | Subcutaneous |