VELOCITY

• Research type

  Research Study

• Full title

  Comparison of 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.

• IRAS ID

  172048

• Contact name

  Peter Clayton

• Contact email

  peter.clayton@manchester.ac.uk

• Sponsor organisation

  Versartis, Inc.

• Eudract number

  2014-004525-41

• Clinicaltrials.gov Identifier

  NCT02339090

• Duration of Study in the UK

  1 years, 8 months, days

• Research summary

  The VELOCITY Study-Long-Acting Growth Hormone in Children compared to Daily recombinant human growth hormone (rhGH).
  The trial will compare a semi-monthly VRS-317 dosing regimen of treatment effect against daily injections of rhGH. Primary data analysis will occur at 12 months. The Sponsor and Investigators will be blinded to the height velocity data during the trial.
  The study population will consist in pre-pubertal children with growth hormone deficiency (GHD) whom have not been treated before.
  Subjects will be treated with VRS-317 or daily rhGH treatment for 12 months.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0253

• Date of REC Opinion

  20 May 2015

• REC opinion

  Further Information Favourable Opinion