Clinical Trial: Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children

Brief Summary: This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

Detailed Summary:
Sponsor: Opko Biologics

Current Primary Outcome: Annual Height Velocity [ Time Frame: 12 months of treatment ]

Annual Height Velocity in cm/year measured after 12 months of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Height velocity at 6 months [ Time Frame: After 6 months of treatment ]
  • Change in height Standard Deviation Score (SDS) [ Time Frame: After 6 and 12 months of treatment ]
    Change in height Standard Deviation Score (compared to normal population of same age group)
  • IGF-1 serum levels [ Time Frame: Once monthly on day 4 after the last dose ]
    IGF-1 and IGFBP-3 serum levels measured once monthly on day 4 after the last dose


Original Secondary Outcome: Same as current

Information By: Opko Biologics

Dates:
Date Received: May 2, 2012
Date Started: February 2012
Date Completion:
Last Updated: November 10, 2015
Last Verified: July 2015