A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders (iNCGS)

Ipsen

Status: Completed

Conditions: Growth Hormone Disorders

Study type: Observational

Funder types: Industry

Identifiers

NCT00455728

2-79-58035-005

EUPAS7948 (Registry Identifier)

Details and patient eligibility

About

This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.

Full description

The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.

Enrollment: 3,690 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children of either sex who are treated with NutropinAq® for the treatment of growth failure
• Patients who are willing to comply with follow-up appointments throughout study participation
• Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable

Exclusion criteria

• Patients not treated with NutropinAq®
• Patients with closed epiphyses
• Patients with active neoplasia