A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
Completed
- Conditions
- Growth Hormone Disorders
- Registration Number
- NCT00455728
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3690
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with adverse events Every 3 months until study completion Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).
- Secondary Outcome Measures
Name Time Method Treatment height measurements until epiphyseal closure is achieved. Every 3 months until study completion
Trial Locations
- Locations (1)
Ipsen Central Contact
🇬🇧Slough, Berkshire, United Kingdom