Clinical Trial: MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

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

Official Title: A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset

  • To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
  • To specify the best period of treatment
  • To assess the efficacy of treatment based on final adult height of these children

    • Detailed Summary:
    Sponsor: Sanofi

    Current Primary Outcome: Efficacy data : measurement of height [ Time Frame: at trimestrial visit ]

    Original Primary Outcome: measurement of height

    Current Secondary Outcome:

    • laboratory test assessment and evaluation of bone age [ Time Frame: at every other visit ]
    • measurement of anti-GH and anti-ECP antibodies [ Time Frame: one visit out of four ]
    • Tolerance data : undesirable events [ Time Frame: throughout the study ]


    Original Secondary Outcome:

    • laboratory test assessment and evaluation of bone age
    • measurement of anti-GH and anti-ECP antibodies


    Information By: Sanofi

    Dates:
    Date Received: March 23, 2007
    Date Started: May 1993
    Date Completion:
    Last Updated: October 4, 2010
    Last Verified: October 2010