Treatment of Children and Adolescents With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

May 26, 2006

Last Updated Date

May 27, 2009

Start Date ^ICMJE

November 2005

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Height Velocity [ Time Frame: during second year of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Height velocity during the second year of rhIGF-1 treatment

Change History

Complete list of historical versions of study NCT00330668 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Height velocities during subsequent years of rh IGF-1 treatment [ Time Frame: during subsequent years of treatment ] [ Designated as safety issue: No ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Height velocities during subsequent years of rhIGF-1 treatment
Height velocity standard deviation (SD) score
Height SD score

Descriptive Information

Brief Title ^ICMJE

Treatment of Children and Adolescents With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency

Official Title ^ICMJE

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

Brief Summary

This is an extension study to Tercica study MS301 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.

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 will be allow to enroll in this extension study. All subjects will 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Primary IGF-1 Deficiency
Growth Disorders

Intervention ^ICMJE

Drug: rh IGF-1 (mecasermin)
Drug: rh IGF-1 mecasermin

Study Arms / Comparison Groups

Experimental: 80 µg/kg BID
Experimental: 120 µg/kg BID

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

135

Estimated Completion Date

October 2010

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Exclusion Criteria:

Incomplete participation in MS301
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

Gender

Both

Ages

4 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00330668

Responsible Party

Rod Van Syoc, Director, Clinical Operations, Tercica, Inc.

Study ID Numbers ^ICMJE

MS306

Study Sponsor ^ICMJE

Tercica

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

George Bright, M.D.

Tercica, Inc.

Information Provided By

Tercica

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP