Versartis Long-Term Extension Study of Somavaratan (VRS-317)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Versartis Inc.
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02068521
First received: February 6, 2014
Last updated: April 22, 2016
Last verified: April 2016
  Purpose

Protocol 13VR3 is designed as an open-label, long-term extension study of the safety and efficacy of a long-acting human growth hormone somavaratan (VRS-317) 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: somavaratan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-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 Somavaratan (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 Somavaratan Administration
Patients will receive long-term repeat dosing of subcutaneous somavaratan once per week.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317
Experimental: Semi-Monthly Somavaratan Administration
Patients will receive long-term repeat dosing of subcutaneous somavaratan twice per month.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317
Experimental: Once Monthly Somavaratan Administration
Patients will receive long-term repeat dosing of subcutaneous somavaratan once per month.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317
Experimental: Twice Monthly Somavaratan Administration
All subjects after participation in (12VR2) or participation in the 14VR4 protocols have the option to participate in the twice monthly dosing of subcutaneous somavaratan.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317

Detailed Description:
This study (13VR3) is designed as an extension study and is a multi-center, parallel dose, open-label study assessing long-term somavaratan administration. It is open to subjects completing a Versartis Phase 2 or 3 study in children with growth hormone deficiency (GHD). Subjects will be initially maintained on the same somavaratan dosing schedule in use at the time of their enrollment in this trial. Subjects entering this study that were not receiving somavaratan (e.g., receiving daily rhGH) will be randomized to an existing somavaratan dosing arm. The study will be conducted at approximately 75 Pediatric Endocrinology centers in the United States, Canada, and Europe.
  Eligibility

Ages Eligible for Study:   3 Years to 12 Years   (Child)
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: William Charlton, MD 650-433-2635 wcharlton@versartis.com

  Show 23 Study Locations
Sponsors and Collaborators
Versartis Inc.
Investigators
Study Director: William Charlton, MD Versartis Inc.
  More Information

Additional Information:
Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02068521     History of Changes
Other Study ID Numbers: 13VR3 
Study First Received: February 6, 2014
Last Updated: April 22, 2016
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
Somavaratan

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

ClinicalTrials.gov processed this record on August 25, 2016