Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2009-01-31

Brief Summary

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This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

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Detailed Description

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Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (\<-2 standard deviations \[SDs\] below the mean for age and gender), and abnormal serum IGF-1 (\<-2 SDs below the mean for age and gender).

The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Conditions

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Insulin-Like Growth Factor-1 Deficiency Growth Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rhIGF-1 QD

Subjects received subcutaneous injection (SC) injections of rhIGF-1 once a day.

Group Type EXPERIMENTAL

rhIGF-1 (mecasermin) for a period of 86 weeks

Intervention Type DRUG

Once a day rhIGF-1 injections

Interventions

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rhIGF-1 (mecasermin) for a period of 86 weeks

Once a day rhIGF-1 injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronological age ≥ 3
* Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
* Prepubertal at Visit 1
* Height SD score of \< -2
* IGF-1 SD score of \< -2

Exclusion Criteria

* Prior treatment with GH, IGF-1, or other growth-influencing medications
* Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
* Chronic illness such as diabetes, cystic fibrosis, etc.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No