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Clinical Trials/EUCTR2004-000644-25-SK
EUCTR2004-000644-25-SK
Active, not recruiting
Phase 1

A Phase II/III, Open-Label, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of Insulin-Like Growth Factor I/ Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3), Administered for 12 Months in Children and Adolescents with Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome.

Insmed Incorporated0 sites40 target enrollmentJune 2, 2004
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ConditionsGrowth Hormone Insensitivity Syndrome (GHIS) is a genetically disturbance of the biological action of growth hormone (GH). This study is intended to evaluate the ability of rhIGF-I/rhIGFBP-3 to demonstrate height velocity increases, in pre-pubertal children with GHIS and to evaluate the safety profile of extended treatment with rhIGF-I/rhIGFBP-3, believed to be more favorable that that observed with rhIGF-I.

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Growth Hormone Insensitivity Syndrome (GHIS) is a genetically disturbance of the biological action of growth hormone (GH). This study is intended to evaluate the ability of rhIGF-I/rhIGFBP-3 to demonstrate height velocity increases, in pre-pubertal children with GHIS and to evaluate the safety profile of extended treatment with rhIGF-I/rhIGFBP-3, believed to be more favorable that that observed with rhIGF-I.
Sponsor
Insmed Incorporated
Enrollment
40
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2004
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •See protocol page 12\.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •See protocol page 12\.

Outcomes

Primary Outcomes

Not specified

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