This trial is active, not recruiting.

Condition growth disorders
Treatments somavaratan, daily rhgh
Phase phase 3
Sponsor Versartis Inc.
Start date January 2015
End date August 2017
Trial size 136 participants
Trial identifier NCT02339090, 14VR4


The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
somavaratan long acting recombinant human growth hormone administered subcutaneously twice-monthly
somavaratan Long acting recombinant human growth hormone
long acting growth hormone therapy
(Active Comparator)
Daily recombinant growth hormone therapy administered subcutaneously every day
daily rhgh daily growth hormone
daily growth hormone therapy

Primary Outcomes

Efficacy (Annual height velocity)
time frame: 12 months

Secondary Outcomes

Pharmacodynamics (IGF-I and IGFBP-3 responses to study drug administration)
time frame: 12 months
Safety as measured by he number of patients with adverse events, concomitant medications, safety labs, vital signs, physical exams, and repeat dose immunogenicity.
time frame: 12 Months

Eligibility Criteria

Male or female participants from 3 years up to 11 years old.

Inclusion Criteria: - Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys). - Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in boys. - Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0 ng/mL. - Height SD score ≤ -2.0 at screening. - Weight for Stature ≥ 10th percentile. - IGF-I SD score ≤ -1.0 at screening. - Delayed bone age (≥ 6 months). Exclusion Criteria: - Prior treatment with any growth promoting agent - History of or concurrent significant disease (e.g. diabetes, cystic fibrosis, renal insufficiency). - Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome. - A diagnosis of Attention Deficit Hyperactivity Disorder. - Daily use of anti-inflammatory doses of glucocorticoid. - Prior history of leukemia, lymphoma, sarcoma or cancer. - 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 and spina bifida variants. - Significant abnormality in screening laboratory studies

Additional Information

Official title Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency.
Description This study is designed as a pivotal study to compare the safety and efficacy of a selected dose regimen of somavaratan to daily rhGH. The study is a randomized, multi-center, open label study of 12 months duration. The primary endpoint is height velocity at 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Versartis Inc..