Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
|ClinicalTrials.gov Identifier: NCT00330668|
Recruitment Status : Terminated (Unacceptable frequency of hypoglycemia observed at and above 200 ug/kg/day)
First Posted : May 29, 2006
Results First Posted : June 27, 2011
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Growth Disorders||Drug: rh IGF-1 (mecasermin)||Phase 3|
Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, subjects that have completed one year of mecasermin treatment on Tercica protocol MS301 (NCT00125164) will be allowed to enroll in this extension study. All subjects were planned to receive treatment.
This is a Phase IIIb open-label, multi-center, parallel dose, extension study conducted in approximately 40 centers across the United States.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recombinant Human Insulin-Like Growth Factor-1 (IGF-1) Treatment of Children With Growth Failure Associated With Primary IGF-1 Deficiency: An Open-Label, Multi-Center, Extension Study|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||March 2010|
- 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.Other Name: Increlex
- Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily) [ Time Frame: after one year of treatment ]Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
- Height Velocities During Subsequent Years of rh IGF-1 Treatment [ Time Frame: after 2, 3 and 5 years of treatment ]Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
- Height Velocity Standard Deviation (SD) Score [ Time Frame: during the course of the study ]
- Height SD Score [ Time Frame: during the course of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330668
|Study Director:||Sr Vice President, Clinical Development and Medical Affairs||Ipsen (formerly Tercica, Inc.)|