European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry (EuIGFD)

• All other non-serious adverse events considered to be drug-related by the paediatric endocrinologist [ Time Frame: follow up to post-treatment visits ] [ Designated as safety issue: Yes ]
• All targeted adverse events [ Time Frame: follow up to post treatment visits ] [ Designated as safety issue: Yes ]
• All clinically significant laboratory abnormalities [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
• Dose of Increlex® at the start of the treatment, dose escalation, concomitant medication, height, weight, pubertal age, predicted Adult Height, height velocity, final adult height, pubertal stage [ Time Frame: periodically assessed during the study until the final adult height is achieved ] [ Designated as safety issue: No ]
• Biological assessment : IGF-1 levels, IGFBP-3 levels, baseline GH concentrations and binding proteins. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
• Genetic test results if available [ Time Frame: throughout study ] [ Designated as safety issue: No ]

• all other non-serious adverse events considered to be drug-related by the paediatric endocrinologist [ Time Frame: follow up to post-treatment visits ] [ Designated as safety issue: Yes ]
• all targeted adverse events whether or not they are considered to be drug-related by the paediatric endocrinologist. The targeted adverse events are: headache, otitis media, papilloedema, hypoglycaemia, acromegalic facial changes & hearing loss [ Time Frame: follow up to post treatment visits ] [ Designated as safety issue: Yes ]
• all clinically significant laboratory abnormalities [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
• dose of Increlex® at the start of the treatment, dose escalation, height, weight, pubertal age, final adult height [ Time Frame: periodically assessed during the study until the final adult height is achieved ] [ Designated as safety issue: No ]

The purpose of this study is to collect long-term safety information on the use of recombinant DNA-derived human Insulin Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with growth failure.

Surveillance registry, defined as a post-authorisation observational registry, called the Eu-IGFD {European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database} which is intended primarily to monitor the safety of Increlex® replacement therapy in children with growth failure and secondly to follow the efficacy of this treatment. Patients who have already started Increlex® therapy before entering this observational registry may be included in this registry and data will be collected retrospectively.

Children with Growth Failure due to Severe Primary IGF-1 Deficiency

Inclusion Criteria:

• All subjects beginning therapy with Increlex® or those previously treated with Increlex® by a participating qualified practitioner
• Parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. Assent from the subject should also be obtained as appropriate

Exclusion Criteria:

• Subject currently participating in an Increlex® clinical trial
• Subject currently participating in any clinical trial for growth retardation