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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00330668

Purpose

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.

Condition	Intervention	Phase
Growth Disorders	Drug: rh IGF-1 (mecasermin)	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Growth Disorders

Drug Information available for: Insulin Insulin-like growth factor I Mecasermin Mecasermin rinfabate

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily) [ Time Frame: after one year of treatment ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Height Velocities During Subsequent Years of rh IGF-1 Treatment [ Time Frame: after 2, 3 and 5 years of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Height SD Score [ Time Frame: during the course of the study ] [ Designated as safety issue: No ]

Enrollment:	114
Study Start Date:	November 2005
Study Completion Date:	March 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	4 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Parents or legally authorized representatives must give signed informed consent before any trial related activities are conducted
Where required, assent of the subject will be appropriately documented prior to any study related activities
Completion of assessments at Visit 9 (Month 120 of Study MS301 [NCT00125164])

Exclusion Criteria:

Incomplete participation in MS301 (NCT00125164)
Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1 injection) or its formulation
Development or presence of a chronic condition except as approved by the Medical Monitor
Pregnancy
Any social or medical condition that, in the opinion of the investigator, would be detrimental to either the subject or the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330668

Locations

France
Ipsen
Paris, France

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Sr Vice President, Clinical Development and Medical Affairs

Ipsen (formerly Tercica, Inc.)

More Information

No publications provided

Responsible Party:	Senior Vice President, Clinical Development and Medical Affairs, Ipsen
ClinicalTrials.gov Identifier:	NCT00330668 History of Changes
Other Study ID Numbers:	MS306
Study First Received:	May 26, 2006
Results First Received:	February 28, 2011
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ipsen:

Insulin-like Growth Factor Deficiency
IGF-1
Short Stature

Additional relevant MeSH terms:

Failure to Thrive
Growth Disorders
Pathologic Processes
Mitogens

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012