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Summary

for people ages 3 years and up
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

Pediatric Growth Hormone Deficiency 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 Hormones

Eligibility

You can join if…

Open to people ages 3 years and up

for Subjects Completing a Previous Somavaratan Study:

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

You CAN'T join if...

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.

Locations

  • Sierra Medical Research accepting new patients
    Clovis, California, 93612, United States
  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles, California, 90027, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Versartis Inc.
Links
Versartis website
ID
NCT02068521
Phase
Phase 2/3
Study Type
Interventional
Last Updated
September 1, 2016
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