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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: Completed Phase 1 study of Growth Hormone Deficiency, sponsored by Versartis.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This study will evaluate the differences between VRS-317 dose levels and placebo for adverse events. Summaries will be provided for each dose cohort and for the combined dose cohorts including the number of patients with adverse events. All subjects who receive at least one dose of VRS-317 or placebo will be included in the safety analysis. Summaries of all adverse events (AEs)and serious adverse events (SAEs)will be classified according to severity and relationship to study drug.
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 |
What the finished NCT01359488 record still lists
NCT01359488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 384-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Growth Hormone Deficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01359488's enrollment target sits among peer trials
50 7th of 16 higher than 10 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency 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.
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