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

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

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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: 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 Tercica:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	135
Study Start Date:	November 2005
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
80 µg/kg BID: Experimental 80 µg/kg BID	Drug: rh IGF-1 (mecasermin) 80 or 120 µg/kg BID
120 µg/kg BID: Experimental 120 µg/kg BID	Drug: rh IGF-1 (mecasermin) 80 or 120 µg/kg BID Drug: rh IGF-1 mecasermin 120 µg/kg BID

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.

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)

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

Contacts and Locations

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

Locations

United States, California
Tercica, Inc.
Brisbane, California, United States, 94005

Sponsors and Collaborators

Tercica

Investigators

Study Director:

George Bright, M.D.

Tercica, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Tercica, Inc. ( Rod Van Syoc, Director, Clinical Operations )
Study ID Numbers:	MS306
Study First Received:	May 26, 2006
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00330668 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tercica:

Insulin-like Growth Factor Deficiency
IGF-1
Short Stature

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Mitosis Modulators

Growth Disorders
Mitogens
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009