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Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency

NCT00330668 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2020-08-14

Study results available
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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 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.

Conditions

  • Growth Disorders

Interventions

DRUG

rh IGF-1 (mecasermin)

Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.

Sponsors & Collaborators

Principal Investigators

  • Sr Vice President, Clinical Development and Medical Affairs · Ipsen (formerly Tercica, Inc.)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-02-28
Completion
2010-03-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330668 on ClinicalTrials.gov