drugset
drugset / Trial / NCT00330668

Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency

NCT00330668 ↗

Phase 3 Terminated 114 enrolled Ipsen
NaSingle-groupOpen-labelTreatment

Summary

This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency (IGFD). The secondary objective is to use the data collected to learn more about the relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.

Timeline

Start
2005-11
Primary completion
2010-02
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject mecasermin Protein / enzyme biologic 40 ug/kg Subcutaneous
Subject mecasermin Protein / enzyme biologic 80 ug/kg Subcutaneous
Subject mecasermin Protein / enzyme biologic 120 ug/kg Subcutaneous
Subject mecasermin Protein / enzyme biologic 240 ug/kg Subcutaneous

Indications

growth delay due to insulin-like growth factor I resistance