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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00903110
First received: April 30, 2009
Last updated: April 29, 2014
Last verified: April 2014
  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
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: Mireille Bonnemaire, 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: April 29, 2014
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 July 20, 2014