IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome - Tabular View

Tracking Information
First Received Date ^ICMJE	August 23, 2006
Last Updated Date	March 29, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00368173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
Official Title ^ICMJE
Brief Summary	STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.
Detailed Description
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition ^ICMJE	Growth Hormone Insensitivity Syndrome (GHIS) Laron Syndrome
Intervention ^ICMJE	Drug: rhIGF-I/rhIGFBP-3
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: A diagnosis of GHIS such as Laron syndrome, 2 - 18 years of age, Height less than or equal to -3SD for age, Pre-pubertal, defined as Tanner breast stage 1 or testis volume <4mL Exclusion Criteria: Children in puberty, Diagnosed malignancy, A diagnosis of diabetes mellitus
Gender	Both
Ages	2 Years to 18 Years
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Brazil, China, Egypt, Germany, Israel, Italy, Norway, Peru, Slovakia, Turkey, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00368173
Responsible Party
Study ID Numbers ^ICMJE	INSM-110-303
Study Sponsor ^ICMJE	Insmed
Collaborators ^ICMJE
Investigators ^ICMJE
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