Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome

This study has been terminated.

(Terminated due to a patent legal settlement)

Sponsor:

Information provided by:

Insmed

ClinicalTrials.gov Identifier:

NCT00351221

First received: July 11, 2006

Last updated: March 29, 2007

Last verified: February 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2006

Last Updated Date

March 29, 2007

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00351221 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome

Official Title ^ICMJE

A Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome

Brief Summary

The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) – insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Noonan Syndrome

Intervention ^ICMJE

Drug: rhIGF-1/rhIGFBP-3

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

A diagnosis of Noonan syndrome
Height less than the 3rd percentile for age and sex (height SDS < -1.88)
Basal IGF-I less than the mean for age and sex (IGF-I SDS < 0)
Chronological age greater than 2 years
Bone age ≤ 11 years for boys, and ≤ 10 years for girls
Pre-pubertal
Documented pre-treatment height velocity less than the mean for age and sex

Exclusion Criteria:

Clinically significant diseases
Chronic illnesses
Prior treatment with rhIGF-1

Gender

Both

Ages

2 Years to 16 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00351221

Other Study ID Numbers ^ICMJE

INMS-110-801

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Insmed

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kenneth Attie, MD

Insmed, Inc.

Information Provided By

Insmed

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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