TerminatedPhase 3

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

Stopped: Unacceptable frequency of hypoglycemia observed at and above 200 ug/kg/day

France114 participantsStarted 2005-11

Plain-language 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.

Who can participate

Age range4 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Height Velocity During BID Dosing Period

Timeframe: At Years 1, 2 and 3 in BID dosing period.

Trial details

NCT IDNCT00330668

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-02

Results submitted2011-02-28

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