Long-Term Treatment With rhIGF-1 in GHIS

Ipsen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Growth Hormone Insensitivity Syndrome

Treatments: Drug: mecasermin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00571727

Study 1419

Details and patient eligibility

About

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Enrollment: 92 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Height <-2SD for age and gender
• IGF-1 <-2SD for age and gender
• Evidence of GH resistance

Exclusion criteria

• closed epiphyses
• prior active malignancy
• major organ disfunction
• treatment with medications that would diminish growth
• clinically significant cardiac abnormalities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

mecasermin, injections BID of rhIGF-1

Experimental group

Treatment:

Drug: mecasermin