IGF-I/IGFBP-3 Therapy in Children and Adolescents With Gr... | NCT00368173

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

NCT00368173

Sponsor

Insmed Incorporated

Status

Completed

Last Update Posted

Sep 13, 2012Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Growth Hormone Insensitivity Syndrome (GHIS)
Laron Syndrome

Interventions

rhIGF-I/rhIGFBP-3

Countries

United States
Argentina
Australia
Brazil
China
Egypt
Germany
Israel
Italy
Norway
Peru
Slovakia
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 23, 2006

First Submission Date that Met QC Criteria

Aug 23, 2006

First Posted Date

Aug 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2012

Last Update Posted Date

Sep 13, 2012Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
rhIGF-I/rhIGFBP-3	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Robert Rapaport, MD		New York	New York		United States
Dr. Alicia Belgorosky

Type	Date	Date Unknown
Release	Jul 5, 2017
Reset	Nov 17, 2017

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D004700	Endocrine System Diseases

ID	Term
D013002	Somatomedins
D000096764	Insulin-Like Peptides
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D001798	Blood Proteins
D011506	Proteins
D001685	Biological Factors