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

Plain-language guide to NCT00330668: phase 3 interventional trial of IGF-1 LR3 and Mecasermin (rhIGF-1), 114 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00330668
Phase: phase 3
Status: terminated early
Start: 2005-11
Completion (planned or actual): 2010-02
Participants: 114 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Growth Disorders
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test IGF-1 LR3 and Mecasermin (rhIGF-1).

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.

It had 1 arm (groups): All rhIGF-1 Subjects (experimental).

The registry classes the interventions as drug.

More on the Plan

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 protocol MS301 (NCT00125164) will be allowed to enroll in this extension study.

All subjects were planned to receive treatment.

Who Took Part

114 actual participants took part.

It was open to people of any sex aged from 4 years up to 15 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 \[NCT00125164\]).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the IGF-1 LR3 study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-11 with completion listed for 2010-02.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3 trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 114 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the IGF-1 LR3 compound page and the Mecasermin (rhIGF-1) compound page, all human trials.

Our Notes on the Compounds

IGF-1 LR3: A modified IGF-1 analog that escapes binding proteins, so it stays active ≥24 h.

Mecasermin (rhIGF-1): FDA-approved recombinant human IGF-1 for severe primary IGF-1 deficiency in children; distinct from IGF-1 LR3 and IGF-1 DES.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.