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Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH (VELOCITY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02339090
First received: January 7, 2015
Last updated: September 26, 2016
Last verified: September 2016
  Purpose
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.

Condition Intervention Phase
Growth Disorders Drug: somavaratan Drug: Daily rhGH Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Versartis Inc.:

Primary Outcome Measures:
  • Efficacy (Annual height velocity) [ Time Frame: 12 months ]
    Annual height velocity


Secondary Outcome Measures:
  • Pharmacodynamics (IGF-I and IGFBP-3 responses to study drug administration) [ Time Frame: 12 months ]
    IGF-I and IGFBP-3 responses to study drug administration

  • 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 ]
    Safety observations will include the number of patients with adverse events, concomitant medications, safety labs, vital signs, physical exams, and repeat dose immunogenicity.


Estimated Enrollment: 136
Study Start Date: January 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: somavaratan
somavaratan long acting recombinant human growth hormone administered subcutaneously twice-monthly
Drug: somavaratan
long acting growth hormone therapy
Other Name: Long acting recombinant human growth hormone
Active Comparator: Daily rhGH
Daily recombinant growth hormone therapy administered subcutaneously every day
Drug: Daily rhGH
daily growth hormone therapy
Other Names:
  • daily growth hormone
  • recombinant growth hormone therapy

Detailed 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.
  Eligibility

Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02339090

  Show 77 Study Locations
Sponsors and Collaborators
Versartis Inc.
Investigators
Study Director: William Charlton, MD Sponsor GmbH
  More Information

Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02339090     History of Changes
Other Study ID Numbers: 14VR4
Study First Received: January 7, 2015
Last Updated: September 26, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Versartis Inc.:
VRS-317
Growth Hormone Deficiency
Long Acting Recombinant Growth Hormone
Long Acting Growth Hormone
Pediatric Growth Hormone Deficiency
Growth Hormone Replacement Therapy
Versartis
Xten
Human Growth Hormone
somavaratan
growth failure

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017