Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD)

Study identification

• EU PAS number:
  EUPAS7708
• Study ID:
  50235
• Official title and acronym:
  Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Poland

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. ; This registry is a Post-Authorisation Safety Study which is intended primarily to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for Severe Primary IGF-1 Deficiency according to the locally approved product information. ; The second objective is to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively. ; For each subject, the Increlex® treatment period duration is at the discretion of the investigator according to his/her judgment on the basis of clinical needs of the subject. ; The Sponsor will attempt to follow the subject until the Final adult height is attained if not reached within the 5 years post treatment period. Safety data analyses are performed every 6 months. In addition, an independent Data Monitoring Committee (DMC) composed of 3 experts in paediatric endocrinology, oncology and statistician are conducting a review of available safety data on at least an annual basis.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Esteve Pharmaceuticals, S.A.

Study timelines

Date when funding contract was signed

Planned:19/06/2008

Actual:19/06/2008

Study start date

Planned:01/01/2009

Actual:09/12/2008

Data analysis start date

Planned:01/12/2010

Actual:01/12/2010

Date of interim report, if expected

Planned:31/12/2025

Actual:15/12/2025

Date of final study report

Planned:31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Esteve Pharmaceuticals, S.A.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)

Other study registration identification numbers and links

NCT00903110

Link to ClinicalTrials.gov