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

This study is currently recruiting participants.
Verified October 2013 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00903110
First received: April 30, 2009
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to collect long-term safety information on the use of recombinant DNA-derived human Insulin 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
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • All targeted adverse events [ Time Frame: follow up to post treatment visits ] [ Designated as safety issue: Yes ]
  • All clinically significant laboratory abnormalities [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Biological assessment : IGF-1 levels, IGFBP-3 levels, baseline GH concentrations and binding proteins. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Genetic test results if available [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Study Design Time Perspective: Retrospective and Prospective


Estimated Enrollment: 3000
Study Start Date: December 2008
Estimated Study Completion Date: December 2099
Estimated Primary Completion Date: December 2099 (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 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.

  Eligibility

Genders Eligible for Study:   Both
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
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: Bruno Fiorentino, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00903110     History of Changes
Other Study ID Numbers: 2-79-52800-002
Study First Received: April 30, 2009
Last Updated: October 29, 2013
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Sweden: Regional Ethical Review Board
Italy: Ministry of Health
Poland: Ethics Committee
Netherlands: CGR (Code of Conduct for Pharmaceutical Advertising)

ClinicalTrials.gov processed this record on April 17, 2014