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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 is a Phase 1 study that has completed, run by Versartis. The registered enrollment target is 64 participants.

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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.

Interventions

  • DRUG Experimental: VRS-317

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2012-10
Est. Completion 2014-07
Phase Phase 1

Sponsor

Versartis

4 total trials

What the Registry Record Tells You About NCT01718041

The ClinicalTrials.gov registry entry for NCT01718041 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Versartis, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Experimental: VRS-317 is the first listed.

NCT01718041 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.