Long-Term Treatment With rhIGF-1 in GHIS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-05-20

Study Completion Date

2011-12-15

Brief Summary

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The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

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Detailed Description

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Conditions

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Growth Hormone Insensitivity Syndrome

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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mecasermin, injections BID of rhIGF-1

Group Type EXPERIMENTAL

mecasermin

Intervention Type DRUG

injections BID of rhIGF-1, mecasermin

Interventions

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mecasermin

injections BID of rhIGF-1, mecasermin

Intervention Type DRUG

Other Intervention Names

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Increlex

Eligibility Criteria

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Inclusion Criteria

* Height \<-2SD for age and gender
* IGF-1 \<-2SD for age and gender
* Evidence of GH resistance

Exclusion Criteria

* closed epiphyses
* prior active malignancy
* major organ disfunction
* treatment with medications that would diminish growth
* clinically significant cardiac abnormalities

Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No