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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00330668 |
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Date of registration:
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26/05/2006 |
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Primary sponsor: |
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Public title:
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Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
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Scientific title:
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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 |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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114 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00330668 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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Sr Vice President, Clinical Development and Medical Affairs |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen (formerly Tercica, Inc.) |
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Disorders
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Intervention(s)
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Drug: rh IGF-1 (mecasermin)
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Primary Outcome(s)
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Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)
[Time Frame: after one year of treatment]
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Secondary Outcome(s)
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Height SD Score
[Time Frame: during the course of the study]
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Height Velocities During Subsequent Years of rh IGF-1 Treatment
[Time Frame: after 2, 3 and 5 years of treatment]
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Height Velocity Standard Deviation (SD) Score
[Time Frame: during the course of the study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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