NCT00368173

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
14 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
Last Updated

September 13, 2012

Status Verified

September 1, 2012

First QC Date

August 23, 2006

Last Update Submit

September 11, 2012

Conditions

Growth Hormone Insensitivity Syndrome (GHIS)Laron Syndrome

Interventions

rhIGF-I/rhIGFBP-3DRUG

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A diagnosis of GHIS such as Laron syndrome,
  • years of age,
  • Height less than or equal to -3SD for age,
  • Pre-pubertal, defined as Tanner breast stage 1 or testis volume \<4mL

You may not qualify if:

  • Children in puberty,
  • Diagnosed malignancy,
  • A diagnosis of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Robert Rapaport, MD

New York, New York, United States

Location

Dr. Alicia Belgorosky

Buenos Aires, Argentina

Location

Dr. Christina Bazan

San Miguel de Tucumán, Argentina

Location

Dr. Bruce King

Newcastle, Australia

Location

Dr. Durval Damiani

São Paulo, Brazil

Location

Dr. Kwok-leung NG

Hong Kong, China

Location

Dr. Mohamed EL Kholy

Cairo, Egypt

Location

Professor Annette Greuters

Berlin, Germany

Location

Tiosano Dov

Haifa, Israel

Location

Maria Carolina Salerno

Naples, Italy

Location

Dr. Hilde Bjorndalen

Oslo, Norway

Location

Dr. Carlos del Aguila

Lima, Peru

Location

Dr. Magdalena Paskova

Košice, Slovakia

Location

Professor Nursen Yordam

Ankara, Turkey (Türkiye)

Location

Dr. Cecilia Camacho-Hubner

London, United Kingdom

Location

MeSH Terms

Conditions

Laron Syndrome

Interventions

Insulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Last Updated

September 13, 2012

Record last verified: 2012-09

Locations

AR(2)IL(1)EG(1)AU(1)US(1)IT(1)NO(1)PE(1)SL(1)TU(1)GB(1)CN(1)DE(1)BR(1)