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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database: a European Registry for Monitoring Long Term Safety and Efficacy of Increlex®. Eu-IGFD

Brief Summary: The Eu-IGFD is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The purpose of this study is to collect long-term safety information on the use of recombinant DNA-derived human Insulin-like Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with growth failure.

Detailed Summary: 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 effectiveness 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.
Sponsor: Ipsen

Current Primary Outcome: Serious adverse events including any occurrence of neoplasia [ Time Frame: throughout study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All other non-serious adverse events considered to be drug-related by the paediatric endocrinologist [ Time Frame: follow up to post-treatment visits ]
  • All targeted adverse events [ Time Frame: follow up to post treatment visits ]
  • All clinically significant laboratory abnormalities [ Time Frame: throughout study ]
  • 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 ]
  • Biological assessment : IGF-1 levels, IGFBP-3 levels, baseline GH concentrations and binding proteins. [ Time Frame: throughout study ]
  • Genetic test results if available [ Time Frame: throughout study ]


Original Secondary Outcome:

  • All other non-serious adverse events considered to be drug-related by the paediatric endocrinologist [ Time Frame: follow up to post-treatment visits ]
  • 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 ]
  • All clinically significant laboratory abnormalities [ Time Frame: throughout study ]
  • 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 ]


Information By: Ipsen

Dates:
Date Received: April 30, 2009
Date Started: December 2008
Date Completion: December 2023
Last Updated: November 30, 2016
Last Verified: November 2016