Versartis Long-Term Extension Study of VRS-317

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Versartis Inc.
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02068521
First received: February 6, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

Protocol 13VR3 is designed as an open-label extension study assessing long-term VRS-317 administration. It is open to subjects completing a Versartis Phase 2 or 3 study in children with growth hormone deficiency.

Patients will be monitored for safety throughout their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs and clinical laboratory determinations. Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE.


Condition Intervention Phase
Pediatric Growth Hormone Deficiency
Drug: VRS-317
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Extension Study of the Safety and Efficacy of A Long-acting Human Growth Hormone (VRS-317) in Children With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Versartis Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Quarterly visits for up to 4 years ] [ Designated as safety issue: Yes ]
    Patients will have quarterly (every 3 months) in clinic visits throughout the study for up to 4 years. Safety assessments include recording of adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations.


Secondary Outcome Measures:
  • Annual Height Velocity [ Time Frame: Annual assessments for up to 4 years ] [ Designated as safety issue: No ]
    Efficacy will be assessed by annual height velocity (cm/yr) in the first year of cumulative treatment (first 12 months) and at each subsequent 12 month interval for up to 4 years.


Other Outcome Measures:
  • Pharmacokinetics and pharmacodynamics (PK/PD) [ Time Frame: Day 1, Month 3, 6 and 12 ] [ Designated as safety issue: Yes ]
    PK/PD peak and trough measurements will be assessed throughout the study with assessment of plasma VRS-317 concentrations and IGF-I and its binding proteins measured at pre-specified time points.


Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Once Weekly VRS-317 Administration
Patients will receive long-term repeat dosing of subcutaneous VRS-317 once per week.
Drug: VRS-317
Subcutaneous injection
Experimental: Semi-Monthly VRS-317 Administration
Patients will receive long-term repeat dosing of subcutaneous VRS-317 twice per month.
Drug: VRS-317
Subcutaneous injection
Experimental: Once Monthly VRS-317 Administration
Patients will receive long-term repeat dosing of subcutaneous VRS-317 once per month.
Drug: VRS-317
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of a Versartis Phase 2 or Phase 3 clinical study in pediatric patients with GHD
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Withdrawal from a Versartis clinical study in pediatric patients with GHD
  • Lack of compliance in a Versartis clinical study in pediatric patients with GHD
  • Use of prohibited medications that may alter responses to the test product
  • Presence of certain medical condition conditions if condition or treatment of condition may alter response to test product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068521

Contacts
Contact: Eric Humphriss, MBA 650-963-8587 ehumphriss@versartis.com
Contact: George Bright, MD 650-963-8589 gbright@versartis.com

Locations
United States, Washington
Recruiting
Seattle, Washington, United States
Contact: Eric Humphriss    650-963-8587    ehumphriss@versartis.com   
Sponsors and Collaborators
Versartis Inc.
Investigators
Study Director: George Bright, MD Versartis Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02068521     History of Changes
Other Study ID Numbers: 13VR3
Study First Received: February 6, 2014
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Versartis Inc.:
Short stature
Growth Hormone Deficiency
Pediatric Growth Hormone Deficiency
GHD
PGHD
VRS-317
Versartis
Growth disorder
Long acting growth hormone
Growth hormone
Weekly growth hormone dosing
Semi-monthly growth hormone dosing
Monthly growth hormone dosing
IGF-I
Height velocity
Annual height velocity
Growth rate

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014