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OpenTrials
Completed

NCT Number: NCT00368173

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

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.

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Key information

Conditions

Growth Hormone Insensitivity Syndrome (GHIS) Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Laron Syndrome Musculoskeletal Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dr. Alicia Belgorosky, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rhIGF-I/rhIGFBP-3

Drug

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Important dates

First posted
Aug 24, 2006
Registry last updated
Sep 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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