FindTrial
Sign In

A Phase 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 Insensitive Syndrome (GHIS) such a Laron Syndrome.

A Phase 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 Insensitive Syndrome (GHIS) such a Laron Syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000644-25-IT
Enrollment
Unknown
Registered
2005-09-21
Start date
2004-10-20
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome. MedDRA version: 6.1 Level: PT Classification code 10005574

Interventions

Product Name: NA Product Code: NA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Mecasermin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5-

Sponsors

INSMED INCORPORATED
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026