Growth Hormone Insensitivity Syndrome
Conditions
Interventions
Trade Name: Increlex
Pharmaceutical Form: Solution for injection
Sponsors
Ipsen Biopharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Height =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Closed epiphyses Prior active malignancy Major organ disfunction Treatment with medications that would diminish growth Clinically significant cardiac abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective was to evaluate the safety and efficacy of long-term replacement therapy with mecasermin in children with growth failure due to severe primary IGF-1 deficiency.;Secondary Objective: Not applicable;Primary end point(s): (1) Annualized Height Velocity (2) Number of Naive Participants With Height Velocity <5 cm/y ;Timepoint(s) of evaluation of this end point: (1) from baseline up to 12 Years (2) at the End of 1 Year of Study Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (3) Height Velocity Standard Deviation Score (4) Height Standard Deviation Score (5) Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height;Timepoint(s) of evaluation of this end point: (3 & 4) Up to 12 Years (5) Up to to 19 Years | — |
Countries
United States
Contacts
Public ContactGlobal Regulatory Affairs
Ipsen Biopaharmaceuticals Inc
Outcome results
None listed