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Versartis Long-Term Safety Study of Somavaratan (VISTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Versartis Inc.
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02068521
First received: February 6, 2014
Last updated: September 26, 2016
Last verified: September 2016
  Purpose

Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration.

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, clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan), PK/PD assessments, and immunogenicity assessments.

Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug dictionary.


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 Safety Study 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: Up to 4 years ] [ Designated as safety issue: Yes ]
    Safety assessments include recording of adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations.


Other Outcome Measures:
  • Evaluate the changes in pharmacodynamics (PD) responses, bone age, weight, height velocity, height standard deviation scores, metabolic parameters, pubertal development and anti-drug antibody responses during long-term somavaratan treatment [ Time Frame: Up to 4 years ] [ 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: 300
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: Treatment naive subjects with GHD
Up to 100 new treatment naïve subjects with GHD will receive somavaratan 3.5mg/kg twice monthly.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317
Experimental: Subjects who have completed a somavaratan study
All subjects after participation in (12VR2) or participation in the 14VR4 protocols have the option to receive somavaratan 3.5mg/kg twice monthly.
Drug: somavaratan
Subcutaneous injection
Other Name: VRS-317

Detailed Description:
Protocol 13VR3 is a multi-center, open-label study assessing long-term somavaratan administration. It is open to subjects completing a somavaratan study in children with growth hormone deficiency (GHD), as well as up to 100 new treatment naïve subjects with GHD. All subjects will receive somavaratan 3.5 mg/kg twice monthly. The study will be conducted at approximately 70 Pediatric Endocrinology centers in the United States, Canada, and Europe.
  Eligibility

Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Subjects Completing a Previous Somavaratan Study:

  1. Completion of a somavaratan clinical study.
  2. Willing and able to comply with all study procedures.

Exclusion Criteria for Subjects Completing a Previous somavaratan Study:

  1. Withdrawal from a somavaratan clinical study.
  2. Use of certain medications with potential to alter responses to the test product.
  3. Presence of a significant medical condition.

Inclusion Criteria for New Treatment Naïve Subjects:

  1. Chronological Age ≥ 3.0 years.
  2. Pre-pubertal status.
  3. Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0 ng/mL.
  4. Normal thyroid function at Screening Visit in subjects not being treated for hypothyroidism.
  5. Normal adrenal function at Screening Visit or within 6 months of the Screening Visit, in subjects not being treated for adrenal insufficiency. Subjects with adrenal insufficiency must receive glucocorticoid treatment for a minimum of 4 weeks before study drug administration.
  6. Pathology relating to cause of GHD must be stable for at least 6 months prior to screening.
  7. Legally authorized representatives must be willing and able to give informed consent.

Exclusion Criteria for New Treatment Naïve Subjects:

  1. Prior/concomitant treatment with any growth promoting agent.
  2. Current, significant disease.
  3. Chromosomal aneuploidy, significant gene mutations or confirmed diagnosis of a named syndrome.
  4. Birth weight and/or birth length less than 5th percentile for gestational age.
  5. Prolonged daily use of anti-inflammatory doses of oral glucocorticoids.
  6. Prior history of malignancy.
  7. Treatment with an investigational drug in the 30 days prior to screening.
  8. Known allergy to constituents of the study drug formulation.
  9. Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
  10. Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation, and spina bifida variants.
  11. Significant abnormality in screening studies.
  12. History of pancreatitis or undiagnosed chronic abdominal pain.
  13. History of spinal or total body irradiation.
  14. Other pituitary hormone deficiencies that are not properly treated.
  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

Locations
United States, California
Sierra Medical Research Recruiting
Clovis, California, United States, 93612
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
University of California San Diego Recruiting
San Diego, California, United States, 92123
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Florida
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Larry C. Deeb, M.D., P.A. Recruiting
Tallahassee, Florida, United States, 32308
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Nancy Wright, M.D., P.A. Pediatric Endocrinology Recruiting
Tallahassee, Florida, United States, 32308
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2624    nsheikh@versartis.com   
United States, Georgia
Van Meter Pediatric Endocrinology, P.C. Recruiting
Atlanta, Georgia, United States, 30318
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Maryland
Barry J. Reiner, M.D., LLC Recruiting
Baltimore, Maryland, United States, 21229
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheik@versartis.com   
United States, Massachusetts
Baystate Medical Center Children's Hospital Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versaartis.com   
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07962-1956
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, New York
Women and Children's Hospital Recruiting
Buffalo, New York, United States, 14222
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Diabetes & Endocrine Center for Children and Young Adults Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: e Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
United States, Washington
University of Washington - Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Eric Humphriss, MBA    650-963-8587    ehumphriss@versartis.com   
Contact: Naureen Sheikh, PhD    650-433-2613    nsheikh@versartis.com   
Sponsors and Collaborators
Versartis Inc.
Investigators
Study Director: Naureen Sheikh, PhD 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: September 26, 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 September 27, 2016