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

PHASE3TerminatedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

February 28, 2010

Study Completion Date

March 31, 2010

Conditions
Growth Disorders
Interventions
DRUG

rh IGF-1 (mecasermin)

Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.

Trial Locations (1)

Unknown

Ipsen, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY