Status:
TERMINATED
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Lead Sponsor:
Ipsen
Conditions:
Growth Disorders
Eligibility:
All Genders
4-15 years
Phase:
PHASE3
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00330668
Start Date
November 1 2005
End Date
March 1 2010
Last Update
August 14 2020
Active Locations (1)
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1
Ipsen
Paris, France