Versartis Long-Term Safety Study of Somavaratan (VISTA)
Pediatric Growth Hormone Deficiency
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About this trial
This is an interventional treatment trial for Pediatric Growth Hormone Deficiency focused on measuring 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
Eligibility Criteria
Inclusion Criteria for Subjects Completing a Previous Somavaratan Study:
- Completion of a somavaratan clinical study.
- Willing and able to comply with all study procedures.
Exclusion Criteria for Subjects Completing a Previous somavaratan Study:
- Withdrawal from a somavaratan clinical study.
- Use of certain medications with potential to alter responses to the test product.
- Presence of a significant medical condition.
Inclusion Criteria for New Treatment Naïve Subjects:
- Chronological Age ≥ 3.0 years.
- Pre-pubertal status.
- Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0 ng/mL.
- Normal thyroid function at Screening Visit in subjects not being treated for hypothyroidism.
- 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.
- Pathology relating to cause of GHD must be stable for at least 6 months prior to screening.
- Legally authorized representatives must be willing and able to give informed consent.
Exclusion Criteria for New Treatment Naïve Subjects:
- Prior/concomitant treatment with any growth promoting agent.
- Current, significant disease.
- Chromosomal aneuploidy, significant gene mutations or confirmed diagnosis of a named syndrome.
- Birth weight and/or birth length less than 5th percentile for gestational age.
- Prolonged daily use of anti-inflammatory doses of oral glucocorticoids.
- Prior history of malignancy.
- Treatment with an investigational drug in the 30 days prior to screening.
- Known allergy to constituents of the study drug formulation.
- Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
- Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation, and spina bifida variants.
- Significant abnormality in screening studies.
- History of pancreatitis or undiagnosed chronic abdominal pain.
- History of spinal or total body irradiation.
- Other pituitary hormone deficiencies that are not properly treated.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment naive subjects with GHD
Subjects who have completed a somavaratan study
Up to 100 new treatment naïve subjects with GHD will receive somavaratan 3.5mg/kg twice monthly.
All subjects after participation in (12VR2) or participation in the 14VR4 protocols have the option to receive somavaratan 3.5mg/kg twice monthly.