Versartis Trial in Children to Assess Long-Acting Growth Hormone
VERTICAL
A Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children With Growth Hormone Deficiency: A Randomized, Open-label, Multi-center, Phase 1b/2a Study of Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy After Subcutaneous Administration for 6 Months
1 other identifier
interventional
64
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2012
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 26, 2022
July 1, 2022
1.7 years
October 19, 2012
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phase 1b and 2a: Evaluate the safety and tolerability of multiple dosing levels of subcutaneous (SC) VRS-317 in pediatric growth hormone deficient (GHD) patients. Phase 2a: Evaluate the efficacy of multiple dose levels of VRS-317
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.
8 Months
Secondary Outcomes (1)
Evaluate pharmacokinetic measures of VRS-317.
8 months
Other Outcomes (2)
Evaluate secondary efficacy measures after 6 months of VRS-317 dosing.
6 Months
Evaluate pharmacodynamic measures
8 Months
Study Arms (1)
VRS-317
EXPERIMENTALActive treatment arm
Interventions
Eligibility Criteria
You may qualify if:
- Chronological Age ≥ 3.0 years and ≤ 11.0
- Diagnosis of GHD as documented by GH stimulation test
- Below average height SDS at screening
- Appropriate weight for Stature
- Decreased IGF-I SDS at screening
- Delayed bone age
- Normal thyroid function test results at screening visit
- Legally authorized representative informed consent.
You may not qualify if:
- Prior treatment with any growth promoting agent
- Documented history of, or current, significant disease
- Chromosomal aneuploidy, significant gene mutations
- Diagnosis of Attention Deficit Hyperactivity Disorder
- Daily use of anti-inflammatory doses of glucocorticoid
- Prior history of leukemia, lymphoma, sarcoma or cancer
- Known allergy to constituents of the study drug formulation
- Abnormal ocular findings at screening
- Significant abnormality in screening laboratory studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Versartis Inc.lead
Study Sites (23)
Unknown Facility
Clovis, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Greenwood Village, Colorado, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Livingston, New Jersey, United States
Unknown Facility
Morristown, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
Sleepy Hollow, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 31, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 26, 2022
Record last verified: 2022-07