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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00903110
First received: April 30, 2009
Last updated: May 29, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
IGF1 Deficiency Drug: Increlex®

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Other
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained
Study Design Time Perspective: Retrospective and Prospective

Estimated Enrollment: 330
Study Start Date: December 2008
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Increlex®
    Increlex® (mecasermin [rDNA origin] injection), 10 mg/ml solution for injection, 20-120mcg/kg BID or 0,02 to 0,12 mg/kg BID, as prescribed by physician
Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with Growth Failure due to Severe Primary IGF-1 Deficiency
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903110

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
United Kingdom
Ipsen Central Contact Recruiting
Slough, Berkshire, United Kingdom
Contact       clinical.trials@ipsen.com   
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Caroline Sert, MD Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00903110     History of Changes
Other Study ID Numbers: 2-79-52800-002
ENCEPP/SDPP/7708 ( Other Identifier: EU PAS Register )
Study First Received: April 30, 2009
Last Updated: May 29, 2017

ClinicalTrials.gov processed this record on July 21, 2017