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Versartis Long-Term Safety Study of Somavaratan (VISTA)

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ClinicalTrials.gov Identifier: NCT02068521
Recruitment Status : Terminated (The primary endpoint of non-inferiority to daily therapy in the pediatric Phase 3 study was not achieved)
First Posted : February 21, 2014
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Pediatric Growth Hormone Deficiency Drug: somavaratan Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 3, 2014
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : November 17, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety [ Time Frame: Up to 4 years ]
    Safety assessments include recording of adverse events and concomitant medications, monitoring of injection sites, vital signs and clinical laboratory determinations.


Other Outcome Measures:
  1. 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 ]
    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.



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068521


Sponsors and Collaborators
Versartis Inc.
Investigators
Study Director: Will Charlton, MD Versartis Inc.

Additional Information:
Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02068521     History of Changes
Other Study ID Numbers: 13VR3
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Versartis Inc.:
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
Short stature
Height velocity
Annual height velocity
Growth rate
Somavaratan

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
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