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Sponsored by: |
Tercica |
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Information provided by: | Tercica |
ClinicalTrials.gov Identifier: | NCT00330668 |
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 |
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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 |
Estimated Enrollment: | 135 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
80 µg/kg BID: Experimental
80 µg/kg BID
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Drug: rh IGF-1 (mecasermin)
80 or 120 µg/kg BID
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120 µg/kg BID: Experimental
120 µg/kg BID
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Drug: rh IGF-1 (mecasermin)
80 or 120 µg/kg BID
Drug: rh IGF-1 mecasermin
120 µg/kg BID
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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.
Ages Eligible for Study: | 4 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rod Van Syoc | 650 238 1598 | rodney.vansyoc@tercica.com |
Contact: Elizabeth Lawson | 650 238 1545 | elizabeth.lawson@tercica.com |
United States, California | |
Tercica, Inc. | Recruiting |
Brisbane, California, United States, 94005 |
Study Director: | George Bright, M.D. | Tercica, Inc. |
Responsible Party: | Tercica, Inc. ( Rod Van Syoc, Director, Clinical Operations ) |
Study ID Numbers: | MS306 |
Study First Received: | May 26, 2006 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00330668 |
Health Authority: | United States: Food and Drug Administration |
Insulin-like Growth Factor Deficiency IGF-1 Short Stature |
Growth Disorders Insulin |
Pathologic Processes |