European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database: a European Registry for Monitoring Long Term Safety and Efficacy of Increlex®. Eu-IGFD
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IGF1 Deficiency
Trial Information
European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database: a European Registry for Monitoring Long Term Safety and Efficacy of Increlex®. Eu-IGFD
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only
Outcome Measure:
Serious adverse events including any occurrence of neoplasia
Outcome Time Frame:
throughout study
Safety Issue:
Yes
Principal Investigator
Bruno Fiorentino, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
Austria: Ethikkommission
Study ID:
2-79-52800-002
NCT ID:
NCT00903110
Start Date:
December 2008
Completion Date:
December 2099
Related Keywords:
- IGF1 Deficiency
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