Status:
COMPLETED
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
Lead Sponsor:
Insmed Incorporated
Conditions:
Growth Hormone Insensitivity Syndrome (GHIS)
Laron Syndrome
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Children in puberty,
- Diagnosed malignancy,
- A diagnosis of diabetes mellitus
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00368173
Last Update
September 13 2012
Active Locations (15)
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1
Robert Rapaport, MD
New York, New York, United States
2
Dr. Alicia Belgorosky
Buenos Aires, Argentina
3
Dr. Christina Bazan
San Miguel de Tucumán, Argentina
4
Dr. Bruce King
Newcastle, Australia