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 range

4 Years – 15 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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