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NCT01718041 · ClinicalTrials.gov registry record · Phase 1
Versartis Trial in Children to Assess Long-Acting Growth Hormone
A Phase 1 study, sponsored by Versartis.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01718041: Completed Phase 1 study, sponsored by Versartis.
NCT01718041 is a Phase 1 study that has completed, run by Versartis. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01718041, a Phase 1 study, has completed, sponsored by Versartis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
Safety observations will include the number of patients with adverse events, concomitant medications, safety labs, vital signs, physical exams, single dose immunogenicity (Phase 1b), and repeat dose immunogenicity (Phase 2a). The primary efficacy outcome measure is the height velocity over 6 months as measured by standing height taken with stadiometer at baseline and after 6 Months of VRS-317 dosing in Phase 2a.
Interventions
- DRUG Experimental: VRS-317
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01718041 record still lists
NCT01718041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Experimental: VRS-317 is the first listed.
NCT01718041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01718041 about?
NCT01718041 is a clinical study titled "Versartis Trial in Children to Assess Long-Acting Growth Hormone". 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 a...
What is the current status of trial NCT01718041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2012-10. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01718041?
The interventions under investigation include: Experimental: VRS-317 (DRUG).
Who is sponsoring clinical trial NCT01718041?
This trial is sponsored by Versartis, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01718041's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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