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NCT01359488 · ClinicalTrials.gov registry record · Phase 1
VRS-317 in Adult Subjects With Growth Hormone Deficiency
A Phase 1 study of Growth Hormone Deficiency, sponsored by Versartis.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01359488 is a Phase 1 study of Growth Hormone Deficiency that has completed, run by Versartis. The registered enrollment target is 50 participants, below the 384-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01359488, a Phase 1 study of Growth Hormone Deficiency, has completed, sponsored by Versartis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients. * Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase) * Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2. * The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose
Conditions Studied
Interventions
- DRUG VRS-317
Study Locations (1)
Texas
- Diabetes and Glandular Disease Clinic - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01359488
The ClinicalTrials.gov registry entry for NCT01359488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 384-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (87% lower). The listed sponsor is Versartis, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 1 intervention - of which VRS-317 is the first listed.
NCT01359488 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01359488 about?
NCT01359488 is a clinical study titled "VRS-317 in Adult Subjects With Growth Hormone Deficiency". The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients. * Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) ...
What is the current status of trial NCT01359488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-03. Estimated completion is 2012-07.
What conditions does trial NCT01359488 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency.
What interventions are being tested in trial NCT01359488?
The interventions under investigation include: VRS-317 (DRUG).
Who is sponsoring clinical trial NCT01359488?
This trial is sponsored by Versartis, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01359488 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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